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Week Ending: December 31st, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Accidental Acetaminophen Poisonings Rise
• Implant Patients Informed of Possible Contamination
• Milk Thistle Ineffective for Liver Disease
• Woman Misses Bad-Blood Payout by Fortnight
• Two New Cases of Hepatitis C This Year
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December 26th, 2005
Accidental Acetaminophen Poisonings Rise
SourceURL:http://www.miami.com
LAURAN NEERGAARD
Associated Press
WASHINGTON - Think popping extra pain pills can't hurt? Think again: Accidental poisonings from the nation's most popular pain reliever seem to be rising, making acetaminophen the leading cause of acute liver failure.
Use it correctly and acetaminophen, best known by the Tylenol brand, lives up to its reputation as one of the safest painkillers. It's taken by some 100 million people a year, and liver damage occurs in only a small fraction of users.
But it's damage that can kill or require a liver transplant, damage that frustrated liver specialists insist should be avoidable.
The problem comes when people don't follow dosing instructions - or unwittingly take too much, not realizing acetaminophen is in hundreds of products, from the over-the-counter remedies Theraflu and Excedrin to the prescription narcotics Vicodin and Percocet.
"The argument that it's the safest sort of has overruled the idea that people cannot take any amount they feel like," says Dr. William Lee of the University of Texas Southwestern Medical Center, who laments that acetaminophen is popped like M&Ms.
Acetaminophen bottles currently recommend that adults take no more than 4,000 milligrams a day, or eight extra-strength pills.
Just a doubling of the maximum daily dose can be enough to kill, warns Dr. Anne Larson of the University of Washington Medical Center.
Yet, "if two is good, 10 is better in some patients' minds," she says with a sigh.
The Food and Drug Administration has long wrestled with the liver risk, warning two years ago that more than 56,000 emergency-room visits a year are due to acetaminophen overdoses and that 100 people die annually from unintentionally taking too much.
A study published this month by Larson and Lee has agency officials weighing whether to revisit the issue.
Over six years, researchers tracked 662 consecutive patients in acute liver failure who were treated at 22 transplant centers. (Acute liver failure is the most severe type, developing over days, unlike chronic liver failure that can simmer for years because of alcohol abuse or viral hepatitis.)
Almost half were acetaminophen-related. More remarkable was the steady increase: Acetaminophen was to blame for 28 percent of the liver poisonings in 1998, but caused 51 percent of cases in 2003.
That makes acetaminophen the most common cause of acute liver failure, the researchers report in the journal Hepatology.
While most patients pulled through with intensive care, 74 died and 23 others received a transplant.
Some 44 percent of the cases were suicide attempts.
But more, 48 percent, were unintentional overdoses, which "isn't hard to do," Larson says.
Say you take Tylenol Cold & Flu Severe for the flu's aches and stuffiness - 1,000 mg of acetaminophen, every six hours. A headache still nags so between doses you pop some Excedrin - 500 mg more of acetaminophen. Switch to Nyquil Cold/Flu at bedtime, another 1,000 mg.
Maybe you already use arthritis-strength acetaminophen for sore joints - average dose 1,300 mg.
Depending on how often they're taken, the total acetaminophen can add up fast.
That's the nonprescription realm. Surprisingly, 63 percent of unintentional overdoses involved narcotics like Vicodin and Percocet that contain from 325 mg to 750 mg of acetaminophen inside each pill.
Some were chronic pain sufferers taking more and more narcotics as their bodies adjusted to the powerful painkillers, not knowing they were getting ever-higher acetaminophen at the same time. Or they added over-the-counter products for other complaints.
Just this month, Larson treated an 18-year-old whose liver crashed after using Vicodin for three or four days for car-crash injuries. "She was just taking too much because her pain was bothering her."
Led by Tylenol manufacturer McNeil Consumer & Specialty Pharmaceuticals, most over-the-counter products now voluntarily list acetaminophen on front labels.
McNeil also runs ads about the risk, saying "if you're not going to read the label, then don't buy our products," says spokeswoman Kathy Fallon.
But how strongly labels warn varies by product. A rule to standardize warnings, urged by FDA's scientific advisers in 2002, still is working its way through the agency.
While FDA runs a consumer education campaign about the liver risk, nonprescription drugs chief Dr. Charles Ganley says the new study suggests the agency may need to further target narcotic-acetaminophen combinations.
Lee wants to copy Britain, which saw a 30 percent drop in severe liver poisonings after restricting how much acetaminophen could be bought at once.
That's unlikely. Meanwhile, the advice is simple: Read drug labels and add up all your acetaminophen, avoiding more 4,000 mg a day. For extra safety, Lee advises no more than 2,000 to 3,000 mg for more vulnerable people, who regularly use alcohol or have hepatitis.
Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
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Implant Patients Informed of Possible Contamination
SourceURL:http://www.latimes.com
A hospital system used bone and skin from a firm suspected of selling untested parts.
NEW YORK-- Flipping through a stack of Christmas cards and catalogs last week, Patricia Battisti came across a letter from the North Shore-Long Island Jewish Health System, the hospital where she underwent surgery in January, but with so many holiday solicitations, she said, she almost set it aside.
Almost a year after doctors implanted human bone in Battisti's back to alleviate pain from a 2003 car accident, the single mother of four learned that her doctor had unwittingly used potentially contaminated body parts.
"I couldn't believe it," said Battisti, 41, of Franklin Square. "I'm so scared for myself."
Dated Dec. 8, the letter said the hospital had indirectly received human bone, skin and tendons from BioMedical Tissue Services of Fort Lee, N.J., which may not have properly screened them for infectious diseases.
"The U.S. Centers for Disease Control and Prevention believes the overall risk of infection is low, but is encouraging patients to have their blood tested for HIV, hepatitis B and C, and syphilis," the letter said.
Battisti was one of 42 patients who got the letter. All underwent implant surgery at one of three of the system's Long Island hospitals between May 2002 and October 2005, said spokesman Terry Lynam.
But health officials have said that tens of thousands of people across the country, and possibly more on Long Island, might have been exposed by untested parts from BioMedical.
Battisti's attorney, Jeffrey Lisabeth of Mineola, said he was preparing to sue the Long Island health system and BioMedical. It's inexcusable that the hospitals weren't more careful and only sent a form letter to contact patients, he said.
"They just delivered a potential death sentence," he said.
But Lynam said the hospitals were not to blame. They were notified in October by the U.S. Food and Drug Administration that BioMedical was accused of illegally buying body parts from a Brooklyn funeral home.
BioMedical is being sued by two New York families who say a relative's body parts were stolen from the grave and sold to the New Jersey company, said their attorney, Sanford Rubenstein of Brooklyn.
"It was not the intention of the decedents to give body parts," he said. "And no one ever asked the families."
Relatives of Masterpiece Theatre host Alistair Cooke, who died last year, also alleged that Cooke's body parts were stolen and sold to BioMedical Tissue Services.
No one could be reached when contacted last week at the company, and its attorney did not return a call for comment. Spokesmen for the FDA and the Brooklyn district attorney's office said they were investigating BioMedical but declined to comment further.
Many of the parts used on Long Island were purchased from BioMedical by a Florida tissue bank responsible for testing and sterilizing every body part it buys.
After hearing about the accusations against BioMedical, Dr. Sebastian Lattuga, who operated on Battisti and others on Long Island, said he called the tissue bank to make sure proper procedures were followed.
He then telephoned each of his patients and sent a letter to every patient he could not reach. Lattuga said he tried two different numbers for Battisti, but both were disconnected.
Battisti said the hospital should have tried harder. "What if I didn't open the letter?"
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Milk Thistle Ineffective for Liver Disease
SourceURL:http://news.yahoo.com
By Anne Harding
NEW YORK (Reuters Health) - Milk thistle, an herbal remedy used worldwide for liver disease, does not appear to be effective, and there is not enough evidence to conclude that it is safe, an international team of researchers has concluded.
"We can't see beneficial effects, we can't exclude harmful effects, and in order to know more we need to do more randomized trials to find out do they actually help," Dr. Christian Gluud of Copenhagen University Hospital in Denmark, the study's lead author, told Reuters Health.
The market for milk thistle is enormous, Gluud noted, given that as many as 1 billion people around the world have liver disease due to alcoholism or hepatitis B or C. It could even be larger, he added, because some people may decide to take milk thistle for prevention.
Gluud and his colleagues reviewed 13 clinical trials of milk thistle for liver disease due to alcoholism or hepatitis B or C. The gold standard for clinical trials is for them to be placebo-controlled and double-blind, meaning neither patients nor the study administrators know whether a patient is taking the real drug or placebo. Just six of the trials analyzed met this standard.
As they report in the American Journal of Gastroenterology, the researchers found no effect of milk thistle versus placebo on mortality rates or liver disease complications. While the remedy appeared to reduce death from liver-related causes when all data was included, an analysis limited to the best-quality studies found no effect.
No increased risk of adverse events was seen with milk thistle, but this does not necessarily mean the remedy is harmless, Gluud said. Even the highest-quality clinical trials, he noted, can miss catching potential harm from drugs.
According to Gluud, herbal remedies should be held to the same standards as conventional medicine. Sellers of such remedies must be required, he said, to have good evidence for any claims they make.
"My advice to people is don't use them before you have seen valid, trustworthy, low bias clinical trials that these drugs may actually benefit you more than they may harm you," he concluded.
SOURCE: The American Journal of Gastroenterology, November 2005.
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December 30th, 2005
Woman Misses Bad-Blood Payout by Fortnight
SourceURL:http://www.stuff.co.nz
By KAMALA HAYMAN
A Golden Bay woman who contracted hepatitis C from a contaminated blood transfusion has missed out on $44,000 in government compensation by two weeks.
Pat Hayter, 89 tomorrow, was given a blood transfusion during a cervical cancer operation in January 1990. The blood was contaminated with hepatitis C.
Ten years later, Hayter began to suffer symptoms of the potentially fatal liver disease -- extreme fatigue and nausea -- and tests confirmed hepatitis C was active.
But her bad run was not over.
In 2000, the Government admitted hepatitis C screening of blood and blood products was not funded until mid-1992 --more than two years after a test became available. It offered $44,000 in compensation to those who became infected with hepatitis C between February 1990 and July 1992.
Hayter's operation fell two weeks outside the eligible dates.
Instead, after a long battle with the Accident Compensation Corporation (ACC), finally settled by the Dispute Resolution Service, she was awarded $505.20 to cover her medical costs --minimal because she was too old for treatment -- plus a weekly impairment allowance of $35.20. Hayter said she now felt "tired all the time" and was convinced her symptoms were more than just old age. "I've always been very energetic and never done anything slowly in my life. Now I have to."
She forced herself to eat, and took sleeping pills at night.
Her companion, David Amos, said that on a recent trip to Motueka, Hayter had to walk a short distance from the car to the shop. "She was shuffling along at a pace that wouldn't tire a snail. It was pathetic to see. That's the hepatitis C."
He said it was "ridiculous" Hayter had not only had to battle ACC for support, but had missed out on government compensation. "The whole thing just stinks."
England and Scotland offered compensation to people infected with hepatitis C from contaminated blood before September 1991 -- not because of government culpability, but "on compassionate grounds", he said.
ACT health spokeswoman Heather Roy said Hayter's case was "very, very unfortunate", and the lesson from the bad-blood saga of the 1990s was that health ministers and the Health Ministry should listen to expert advice and "not assume they know best".
The Christchurch manager of the Hepatitis C Resource Centre, Bill Jang, said Hayter should challenge her exemption. His organisation was forming a database of those similarly affected.
The Haemophiliac Foundation has also been pushing for government compensation for victims of contaminated blood products dating back to the late 1980s. In April, it proposed a compensation deal that the Government is still considering.
Yesterday, Health Minister Pete Hodgson's press secretary, Jason Knauf, was unable to comment on what stage this process had reached. However, he said Hayter should write directly to Hodgson explaining her situation.
A Health Ministry spokeswoman said if Hayter's condition was deteriorating, she could apply to ACC for a review of her case.
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Medivir: Candidate Drug Designated within the Tibotec Collaboration
SourceURL:http://www.finanznachrichten.de
The Hepatitis C Virus (HCV) collaboration with Tibotec Pharmaceuticals Ltd has recently designated a Candidate Drug (CD). The aim of the research collaboration is to identify and develop orally active inhibitors of the HCV protease NS3/4A. The collaboration was initiated in November 2004 and attaining a CD designation represents an important step on the way towards clinical development.
Separately, the first milestone for preclinical development has been reached in the program, triggering a milestone payment to Medivir (Nachrichten) of EUR 5m.
"Hepatitis C is a highly interesting area for the development of new, innovative pharmaceuticals, and there is a huge need for new treatment principles. It is enormously satisfying that this project with joint resources and efforts has reached such an important development stage as the designation of a CD. We are extremely pleased with the collaboration and the pace it is progressing", says Medivir's VP Research Bertil Samuelsson.
"The designation of this Candidate Drug is the third in a row of protease-based CDs which we have achieved in less than two years. This further validates the productivity of our protease research engine. It enhances the prospects of entering clinical trials over the next few years with several protease inhibitor projects, targeting large patient populations", comments Medivir CEO Lars Adlersson.
Hepatitis C is caused by the RNA virus HCV. The WHO considers that 3% of the global population is infected with HCV, meaning some 200 million individuals. In the USA, 1.8% of the population is infected, which represents 3.9 million individuals. Around 2 million people have the confirmed diagnosis Hepatitis C in the West. In more than 60% of cases, HCV infection leads to protracted illness and handicap. It is the most common cause of chronic liver disease and of liver tumors and the most common ground for liver transplantation. The HCV market is currently dominated by interferon-based treatments which have limitations as regards to efficacy and are causing side-effects. Datamonitor expects the HCV market to grow rapidly from today's USD 3.6 billion to USD 9 billion by the year 2010.
For additional information, please see Medivir's website www.medivir.com
The Medivir Group
Medivir (STO:MVIRB) is an innovative, specialist research company that develops drugs with the objective of becoming a sustaining, profitable pharmaceuticals company. Medivir is located in Huddinge, Sweden and at Chesterford Research Park, Essex, UK.
Medivir's research is oriented on developing new drug compounds based on proteases as target enzyme. The group consists of Medivir AB, its subsidiary Medivir UK Ltd, Medivir HIV Franchise AB and Medivir Personal AB. As of 30 September, the group had 129 employees. Medivir was listed on the Stockholm Exchange O-list in 1996.
Medivir's research portfolio includes projects against hepatitis C, cold sores, osteoporosis, osteoarthritis, rheumatoid arthritis (RA), asthma, multiple sclerosis (MS) and autoimmune disorders. Medivir has five projects in various development phases, whereof one is on its way to phase III.
Medivir HIV Franchise AB focuses on development and divestment of the HIV projects and to ascertain the clinical strategy for MIV-606 against shingles.
Medivir AB (publ.), Lunastigen 7, SE-141 44 Huddinge, Sweden. Phone (switchboard): +46 (0)8 5468 3100
This information was brought to you by Waymaker http://www.waymaker.net
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Two New Cases of Hepatitis C This Year
SourceURL:http://www.shetlandtoday.co.uk/
THE NUMBER of people in Shetland diagnosed with the hepatitis C virus is running at just over a quarter of the national average rate.
During 2004 two new cases were reported, down slightly on the average for Shetland over the past decade of 2.3 each year.
Health Protection Scotland has reported that there are 27 cases on record in Shetland of which 15 were from intravenous drug use. Two were caused by blood factor, such as by transfusion, before heat treatment was introduced in the mid-1980s.
Three others were put down to a variety of possible causes including sexual contact, tattoing or body piercing, bites and blood spillage. The cause of the remaining seven cases is not known.
In Scotland as a whole 1624 new cases were reported last year, the lowest for seven years. It equates to a rate of 32 cases per 100,000 people while the rate in Shetland was the equivalent of 9.1 per 100,000.
Orkney has had a consistently lower rate than Shetland and the Western Isles has recorded only one case in a decade, despite its larger population.
Overall, although one in 300 of Scotland's population is known to have hepatitis C the number of unknown cases is estimated to be twice that rate.
By far the worst affected health board area is Greater Glasgow with double the national incidence, followed by Dumfries & Galloway and Ayrshire & Arran.
The disease affects the liver and is spread by contact with infected blood. Most infected people have no symptoms and are unaware they are carrying it.
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