Tuesday, February 15, 2011

Hepatitis C News;Recalled Alcohol Prep Pads possibly linked to the death of a child

Recently the FDA recalled Triads alcohol prep pads, these pads are used by cancer and HCV patients. It was reported today that the pads have possibly been linked to the death of a child.

Recall ; The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States
Pharmaceuticals has become aware of a broad United States market recall of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names.

Parents blame toddler's death on tainted alcohol wipes

"All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled. The reason? Potential contamination with Bacillus cereus."
The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis.

Sandra and Shanoop Kothari say their lively, dark-eyed toddler, Harrison, was recovering just fine from surgery to remove a benign cyst from near his brain and spinal cord last fall. But the day before he was set to be discharged after a week's stay, he developed a sudden and severe infection that worsened rapidly, causing multi-organ failure that led to Harrison’s death on Dec. 1, 2010.
Cultures showed he succumbed to acute bacterial meningitis caused by Bacillus cereus, bacteria typically found in rare food poisoning outbreaks, but not in hospital infections.
“They had no explanation as to how he contracted it,” said Sandra Kothari, 37, Harrison’s mother. “They know it’s rare in the hospital.”

Rare bacteria detected

For more than a month, the family grieved without knowing the cause of their loss. Then, on Jan. 5, a relative saw a notice posted online by the U.S. Food and Drug Administration. All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled.
The reason? Potential contamination with Bacillus cereus.
“These wipes were used in his care every single day, multiple times a day,” said Shanoop Kothari, Harrison’s father.
Lawyers filed a complaint Sunday in U.S. District Court in Houston. It charges the Triad Group of Hartland, Wis., with gross negligence and seeks damages for the loss of Harrison’s life.
Continue reading........
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Previously Published @ Pharmacy News;
Drug Makers Warn Of Potential Contamination of Alcohol Pads
Several drug makers, including Pfizer Inc. (PFE) and Merck & Co. (MRK), are warning users of certain injectable drugs not to use the disinfecting pads or swabs that came with the drugs, citing possible contamination.
The alcohol prep pads and swabs, which are used to disinfect the skin prior to an injection, were recalled earlier this month by the supplier, Triad Group, due to concerns about potential contamination by an organism that can cause life- threatening infections. Triad, of Hartland, Wis., said it had received one report of a non-life-threatening skin infection “out of hundreds of millions of products sold.”
Since Triad’s recall notice, several drug makers have issued separate alerts about the recall. Pfizer and its partner Progenics Pharmaceuticals Inc. (PGNX) said Tuesday they have suspended shipments of injectable formulations of anti- constipation drug Relistor until the Triad-supplied alcohol pads can be replaced. The companies said they would resume shipments as soon as possible.
A Pfizer spokesman said the suspended shipments would have no significant financial impact, and that single vials of Relistor continue to be sold.
Merck said Triad pads were distributed with Pegintron, a treatment for hepatitis C, and a related drug, Intron A, outside the U.S. Merck said drugs distributed in the U.S. aren’t affected. Merck said it will begin packaging orders for the drugs without alcohol prep pads until a suitable alternative has been identified.
GlaxoSmithKline PLC (GSK) said some of the Triad pads may have been included in U.S. packaging for starter kits for the blood-thinning drug Arixtra.
Roche Holding AG (RHHBY) said Triad pads are distributed with several drugs including the Boniva bone-building drug and hepatitis C treatment Pegasys. Bayer AG (BAYRY) said the Triad pads are packaged for use in the U.S. with multiple- sclerosis drug Betaseron.
In addition, Health Canada said Teva Pharmaceutical Industries Ltd. (TEVA) is advising patients taking the Copaxone MS drug not to use any Triad pads.
The drug companies said their medicines weren’t contaminated, and that they can continue to be used as directed, except that any Triad pads or swabs should be discarded.
Triad said in early January the recalled products were distributed in the U.S., Canada and Europe. Some were made for third parties including drug distributor Cardinal Health Inc. (CAH) and pharmacy chains Walgreen Co. (WAG) and CVS Caremark Corp. (CVS).
As alternatives, patients are advised to use pads or swabs supplied by other manufacturers, or use a gauze pad or cotton ball to administer 70% isopropyl alcohol to the injection site.


IL28B Genomic-Based Treatment Paradigms for Patients With Chronic Hepatitis C Infection: The Future of Personalized HCV Therapies - pdf attached - Download the PDF here- From Jules: We are unsure right now exactly how & to what extent IL28B will be used, we are awaiting further outcomes analyses from the recently reported studies of boceprevir & telaprevir (the new oraly administered protease inhibitors that will be used in combination with peg/rbv). Patients may be "profiled" based on IL28B genotype and other important clinical features (such as fibrosis, age, insulin resistance, viral load, and race) to better predict treatment response (Table 1). Host IL28B genotype is the strongest pretreatment predictor of response through its effect on viral kinetics.....Genotyping of this polymorphism will aid clinical decision making for both current standard of care and potentially for the integration of other agents in the future

Editorial: Effect of Atorvastatin, Vitamin E and C on Nonalcoholic Fatty Liver Disease: Is the Combination Required? - FATTY LIVER IN HIV From Jules: fatty liver in HIV+ is a bigger concern than realized, I think it might emerge as patients age as more of a problem, fatty liver is associated with liver function abnormalities, hepatitis, higher ALTs, so we might expect higher rates of liver disease unrelated to HCV or HBV in aging HIV+ individuals

Surveillance for hepatocellular carcinoma (HCC) in patients with cirrhosis is recommended but 17% received regular testing for HCC(liver cancer) - Download the PDF here - The incidence of hepatocellular carcinoma (HCC) in the United States has more than doubled during the past two decades.....Several consensus conferences as well as two professional organizations have recommended regular HCC surveillance for patients with cirrhosis who are at risk of developing HCC.10-16 Findings from this study suggest that these recommendations have not been well adopted into clinical practice. In this population-based study, fewer than 20% of HCC patients with previously recorded cirrhosis received the recommended regular surveillance. Approximately 69% of these patients had HCV, HBV, or alcoholic liver disease recorded prior to their HCC diagnosis........The incidence of hepatocellular carcinoma (HCC) in the United States has more than doubled during the past two decades

Pharmasset to Present at the Leerink Swann Hot Topics Roundtable Conference
Pharmasset, Inc.
February 14, 2011 5:12pm EST
PRINCETON, N.J., Feb. 14, 2011 — /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the Leerink Swann Hot Topics Roundtable Conference being held February 16 - 17, 2011 at the Roosevelt Hotel, New York, NY. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide a review of the Company's HCV drug pipeline at the conference at 1:30 PM (ET) and Dr. Michelle Berrey, Pharmasset's Chief Medical Officer will be participating in an HCV panel discussion at 4:10 PM (ET).
To access a simultaneous webcast of Mr. Price's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast. A replay of the webcast will be available on Pharmasset's website for thirty days following the conference. Read more

Where you live drives wait for liver transplants

WASHINGTON — Doctors dropped another bomb soon after telling Matthew Rosiello it was time for a liver transplant: The 21-year-old isn't likely to get one any time soon in his home state of New York. Consider traveling to Ohio, they advised, where the wait's a lot shorter.
Where you live plays a big role in how sick you are, and how long you wait, before getting a scarce liver transplant — if you survive long enough. Now the network that runs the U.S. organ transplant system is exploring steps to ease some of the disparities. Critics who want more nationwide sharing of donated livers fear any changes won't help enough.
"I'll go anywhere for my son. This is his life," says Matthew's mother, Randy Rosiello of New York City, who has begun researching waiting lists from Ohio to North Carolina as the family debates its next step.

But she doesn't think her son should have to leave his doctors at New York's Mount Sinai Medical Center, or undergo the stress of travel. Plus, she worries, "if I have to go, I'm putting my family into financial ruin."

The nation has a severe shortage of donated livers. More than 16,000 people are awaiting a liver transplant, and just 6,300 a year get one. More than 1,400 others die waiting each year.
Since 2002, the sickest patients have been ranked atop waiting lists to receive a liver from a deceased donor. They're given a so-called MELD score, based on laboratory tests, that predicts their risk of death. Rising scores move them up on the waiting list. The change by all accounts has greatly improved the system, which once was based instead on time spent waiting.
Here's the lingering trouble: Patients with liver failure and would-be donors are not distributed evenly around the country. And the nation is divided into 11 transplant regions that have wide variations in patients and available organs, between regions and within them.
A donated liver is offered first to the sickest patients in the local transplant center, and if there's no good match, then to the sickest patients throughout that transplant region. If there's still no good match, the liver can go to someone who's not as sick — rather than to someone sicker in the next transplant region.

Patients can shop around for shorter lines, even get on more than one list, if they have the means to get to a far-away hospital within hours of a liver becoming available. For instance, Apple CEO Steve Jobs' 2009 liver transplant was in Tennessee, where the wait was much shorter than back home in California.

But Mount Sinai liver transplant chief Dr. Sander Florman says that system isn't fair to those who can't afford to maximize their chances.
"If a patient can get on an airplane and go to Florida, why can't the liver get on an airplane and come to New York?" he asks.

For patients like Matthew Rosiello, the news that New Yorkers wait longer for a liver complicates already agonizing treatment choices.

When he was a baby, Rosiello had complex liver surgery for a rare birth defect, biliary atresia, and more surgery a few years ago that postponed a transplant. But now repeated liver infections and other complications have put him in the hospital three times in about a month, require IV care and forced him to quit college. Still, his MELD score is low, something doctors warn could change rapidly — but that also means he should consider a place with a shorter wait.
"He's frightened to death," says Randy Rosiello as the family peruses an Internet database — the Scientific Registry of Transplant Recipients — that compares wait times and success rates.
How big are the differences? The United Network for Organ Sharing says that in three regions stretching from Ohio down through Tennessee and on to Florida, adults receiving new livers in the past year had median MELD scores of 23 to 24. But in the New York and western Vermont region, liver recipients were far sicker, with a median score of 32. Only the region that includes California fared worse, with 37.

Within regions, rates of people who die on the waiting list or become too sick to transplant range from fewer than 10 percent to more than 25 percent each year.
So UNOS' liver committee is seeking feedback from transplant centers about options to improve, in hopes of proposing changes later this year.
Topping the list: If a liver isn't a good match to the sickest patients within one region — as measured by a MELD of 15 or more — offer it nationwide before giving it to a less sick local patient.

But small steps won't help the toughest regions, contends Mount Sinai's Florman.
New York transplant centers suggest splitting the country into four or five "super regions" where the sickest patients in the entire zone would get first dibs. No, livers don't last outside the body as long as kidneys that often are shipped long distances. But Florman says his hospital successfully flies in livers from Florida that hospitals there turn down as less-than-optimal — because, say, the donor was elderly — meaning better organs should have no problem.
And often less-than-optimal organs go to waste, because of restrictions on when hospitals can take a chance with them, adds Dr. Thomas Fishbein of Georgetown University Hospital in Washington, D.C., another hard-hit area.

Bigger moves would encounter more resistance, cautions Dr. Kenneth Washburn of the University of Texas Health Science Center, who chairs UNOS' liver committee and views modest change as an important first step. A proposal for regional sharing that skipped the local transplant center prompted "a lightning rod" of objections from hospitals that stood to lose organs, he says.

Indeed, centers with shorter waits say they do a good job of encouraging organ donations and other regions should try to improve.

"If you equate it to hunger, people try to figure out how to come up with more food, not which kid gets the sandwich," says Dr. Joseph Tector, transplant chief at Indiana University Health.
While short-term relief is needed, more organ donation is the long-term answer, agrees Georgetown's Fishbein: "It's only because we're so short of livers that we fight over the livers that are there."
EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Transplant center data: http://www.srtr.org/
United Network for Organ Sharing: http://www.unos.org/

Hepatitis C victim one of first in bungled blood test at Central Coast clinic

CANCER patients already reeling from last week’s revelation the same needle was used on 54 patients were horrified this week to discover one of them suffered from hepatitis C.
Peter Lambert was distraught to find he was one of the first patients on whom an Accu-Chek Multiclix blood testing device was used for pin prick tests at PRP Diagnostic Imaging at Gosford between November 23 and January 20.
“I contracted hepatitis C about nine years ago when I trod on a needle and am in complete shock over the entire incident,” Mr Lambert said.
He said he was pricked twice on November 30 and four times on December 7 prior to PET scans.
The device was used on 54 cancer patients to check their blood before PET scans and two staff members before it was discovered the needle needed to be changed manually.
Mr Lambert said he had filled out a form on November 30 outlining the medications he was on.
“I can’t say for sure if I put on that form I had hepatitis C but my oncologist organised for me to have the PET scan and surely that information would have been on my file,” he said.
Coral Walker, whose partner Ian Whittaker was the 20th patient on whom the needle was used, said she was horrified and very angry.
“I am terrified to tell Ian - he is already so weak,” she said. “His immune system is already so low - I am very frightened,” she said.
Ms Walker said she had written to state and federal health ministers for reassurance such a thing would never happen again.
PRP Diagnostic Imaging chairman Michael Jones said the company was committed to supporting its patients at this difficult time.
“We instigated last week a process to determine their individual level of risk following this incident,” Dr Jones said.
“Patient confidentiality prevents our making any further comment until this process is completed.”

HIV Regimens Similar but Not Equivalent A large clinical trial fell short of showing that two commonly used approaches to a first anti-HIV treatment regimen are formally equivalent.

Healthy You

Updates on the blog;

Vitamin D; "D" Is for Debate

Prepared Patient: Side Effects: When Silence Isn't Golden

Cirrhosis; Surgery in the Patient with Liver Disease

Undefined Liver Failure Linked to Acetaminophen

Public Release: 15-Feb-2011 Journal of Clinical Sleep Medicine

Poor sleep quality is associated with greater disability in rheumatoid arthritis patients A study in the Feb. 15 issue of the Journal of Clinical Sleep Medicine found that poor sleep quality correlated with higher levels of depressive symptoms, greater pain severity, increased fatigue, and greater functional disability in patients with Rheumatoid Arthritis (RA). The study suggests that addressing sleep problems via pharmacological or behavioral interventions may have a critical impact on the health and lives of patients with RA. National Institutes of Health

People Warned Over Adulterated Herbal Weight Loss Pill - Test Results Reveal Twice The Prescribed Dose Of Banned Pharmaceutical Ingredient, UK
14 February 2011 The Medicines and Healthcare products Regulatory Agency (MHRA) continues to warn people about the herbal weight loss product 'Herbal Flos Lonicerae (Herbal Xenicol) Natural Weight Loss Formula' after test results have now...

Do You Take Vitamins?
11 February 2011 A walk down the vitamin aisle can be overwhelming, especially when it comes to choosing between the dizzying array of products and brands. Do you know what to look for to ensure your vitamins provide the nutrients you need...

Vivacta Initiates Development Of Point Of Care Test For Vitamin D
10 February 2011 Vivacta Limited, the medical diagnostics company with a revolutionary system for point-of-care testing, announces it has initiated development of a new rapid diagnostic test for measuring Vitamin D..

From India

Govt bans nimesulide banned over adverse effects on liver

The government has banned the paediatric use of the common fever and pain drug nimesulide for its adverse effects on the liver, in a much- delayed move.The decision was taken by the Union health ministry after experts on the Drug Technical Advisory Board recommended banning the drug along with five others. The ministry decided last week to ban the sale, distribution and manufacture of nimesulide's paediatric formulation along with cisapride, phenylpropanolamine, human placenta extract and sibutramine and R- sibutramine." A notification on the ban is expected in a day or two," officials said. But experts said the decision has come too late.Nimesulide causes liver failure, while cisapride, an anti- acidity drug causes heart abnormality.Phenylpropanolamine, used in cough syrups, increases the risk of strokes. Human placenta extract, being promoted for reducing radiation side effects and female infertility, has no known efficacy, while sibutramine, an anti- obesity drug, is associated with increased risk of heart attacks." These drugs should have been banned 10 years ago. They are banned in all developed countries," Dr C. M. Gulati, the editor of Monthly Index of Medical Specialties , said.Nimesulide tablets for adults, with a market of Rs 2710 crore in India, should also have been banned, Gulati added.

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