July 30, 2010

[Posted 07/30/2010]

AUDIENCE: Consumers, Emergency Medicine

ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

BACKGROUND: MMS is distributed on Internet sites and online auctions by multiple independent distributors. MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

RECOMMENDATIONS: Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

[07/30/2010 - News Release - FDA]

Source
Gastroenterology
Volume 139, Issue 2 , Pages 510-518.e2, August 2010

Piero Amodio, Lorenzo Ridola, Sami Schiff, Sara Montagnese, Chiara Pasquale, Silvia Nardelli, Ilaria Pentassuglio, Maria Trezza, Chiara Marzano, Cristiana Flaiban, Paolo Angeli, Giorgio Cona, Patrizia Bisiacchi, Angelo Gatta, Oliviero Riggio

Received 31 December 2009; accepted 29 April 2010. published online 13 May 2010.

Abstract

Background & Aims
Quantification of the number of noninhibited responses (lures) in the inhibitory control task (ICT) has been proposed for the diagnosis of minimal hepatic encephalopathy (MHE). We assessed the efficacy of ICT compared with recommended diagnostic standards.

Methods
We studied patients with cirrhosis and healthy individuals (controls) who underwent the ICT at 2 centers (center A: n = 51 patients and 41 controls, center B: n = 24 patients and 14 controls). Subjects were evaluated for MHE by psychometric hepatic encephalopathy score (PHES). Patients from center B also were assessed for MHE by critical flicker frequency and spectral electroencephalogram analyses.

Results
Patients with cirrhosis had higher ICT lures (23.2 ± 12.8 vs 12.9 ± 5.8, respectively, P < .01) and lower ICT target accuracy (0.88 ± 0.17 vs 0.96 ± 0.03, respectively, P < .01) compared with controls. However, lures were comparable (25.2 ± 12.5 vs 21.4 ± 13.9, respectively, P = .32) among patients with/without altered PHES (center A). There was a reverse, U-shaped relationship between ICT lure and target accuracy; a variable adjusting lures was devised based on target accuracy (weighted lures at center B). This variable differed between patients with and without MHE. The variable weighted lures was then validated from data collected at center A by receiver operator characteristic curve analysis; it discriminated between patients with and without PHES alterations (area under the curve = 0.71 ± 0.07). However, target accuracy alone was as effective as a stand-alone variable (area under the curve = 0.81 ± 0.06).

Conclusions
The ICT is not useful for the diagnosis of MHE, unless adjusted by target accuracy. Testing inhibition (lures) does not seem to be superior to testing attention (target accuracy) for the detection of MHE.

Keywords: Electroencephalogram, EEG, Attention, Inhibition

Abbreviations used in this paper: CFF, critical flicker frequency, EEG, electroencephalogram, ICT, inhibitory control task, HE, hepatic encephalopathy, LTT, line tracing test, MHE, minimal hepatic encephalopathy, PHES, psychometric hepatic encephalopathy score, ROC, receiving operative curves, TMT, trail making test, WL, weighted lures.

Conflicts of interest The authors disclose no conflicts.

Funding Supported by grants of the University of Padua (to P.A.) and of the University of Rome (to O.R.) and by a “Young Investigator Award” given (to L.R.) by the Italian Society of Gastroenterology (SIGE).

PII: S0016-5085(10)00677-3

doi:10.1053/j.gastro.2010.04.057

© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Source
Gastroenterology
Volume 139, Issue 2 , Pages 499-509, August 2010
 
Masao Honda, Akito Sakai, Tatsuya Yamashita, Yasunari Nakamoto, Eishiro Mizukoshi, Yoshio Sakai, Taro Yamashita, Mikiko Nakamura, Takayoshi Shirasaki, Katsuhisa Horimoto, Yasuhito Tanaka, Katsushi Tokunaga, Masashi Mizokami, Shuichi Kaneko, Hokuriku Liver Study Group

Received 9 October 2009; accepted 14 April 2010. published online 30 April 2010.

Abstract

Background & Aims
Multiple viral and host factors are related to the treatment response to pegylated-interferon and ribavirin combination therapy; however, the clinical relevance and relationship of these factors have not yet been fully evaluated.

Methods
We studied 168 patients with chronic hepatitis C who received pegylated-interferon and ribavirin combination therapy. Gene expression profiles in the livers of 91 patients were analyzed using an Affymetrix genechip (Affymetrix, Santa Clara, CA). The expression of interferon-stimulated genes (ISGs) was evaluated in all samples by real-time polymerase chain reaction. Genetic variation in interleukin 28B (IL28B; rs8099917) was determined in 91 patients.

Results
Gene expression profiling of the liver differentiated patients into 2 groups: patients with up-regulated ISGs and patients with down-regulated ISGs. A high proportion of patients with no response to treatment was found in the up-regulated ISGs group (P = .002). Multivariate logistic regression analysis showed that ISGs (<3.5) (odds ratio [OR], 16.2; P < .001), fibrosis stage (F1-F2) (OR, 4.18; P = .003), and ISDR mutation (≥2) (OR, 5.09; P = .003) were strongly associated with the viral response. The IL28B polymorphism of 91 patients showed that 66% were major homozygotes (TT), 30% were heterozygotes (TG), and 4% were minor homozygotes (GG). Interestingly, hepatic ISGs were associated with the IL28B polymorphism (OR, 18.1; P < .001), and its expression was significantly higher in patients with the minor genotype (TG or GG) than in those with the major genotype (TT).

Conclusions
The expression of hepatic ISGs is strongly associated with treatment response and genetic variation of IL28B. The differential role of host and viral factors as predicting factors may also be present.

Keywords: Pegylated Interferon, Ribavirin, Gene Expression, Single Nucleotide Polymorphism

Abbreviations used in this paper: aa, amino acid, AST, aspartate aminotransferase, cDNA, complementary DNA, CH-C, chronic hepatitis C, Down-ISGs, down-regulated ISGs, EVR, early virologic response, GWAS, genome-wide association studies, HCV, hepatitis C virus, IFN, interferon, IFI44, interferon-induced protein 44, IFIT1, interferon-induced protein with tetratricopeptide repeats 1, IL, interleukin, IL28B, interleukin 28B, ISDR, interferon sensitivity determining region, ISGs, interferon stimulated genes, Mx1, myxovirus (influenza virus) resistance 1 interferon-inducible protein p78 (mouse), NR, no response, Peg, pegylated, RBV, ribavirin, ROC, receiver operating characteristic, RTD, real-time detection, PCR, polymerase chain reaction, RTD-PCR, real-time detection-polymerase chain reaction, SNP, single nucleotide polymorphism, SVR, sustained viral response, TR, transient response, Up-ISGs, up-regulated ISGs

Participating investigators are listed in Appendix 1.

Conflicts of interest The authors disclose no conflicts.

Funding This work was supported in part by a grant-in-aid from the Ministry of Health, Labour and Welfare of Japan.

PII: S0016-5085(10)00657-8

doi:10.1053/j.gastro.2010.04.049

© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Source
SUMMARY: People with chronic hepatitis C are more likely than those never infected to have diabetes and visceral fat accumulation, but have lower levels of LDL "bad" cholesterol, according to a study described in the June 28, 2010 advance online issue of Gut. After HCV clearance, LDL levels rose to match those of never-infected individuals, but glucose levels and abdominal fat remained similar. After adjusting for other risk factors, chronic hepatitis C patients had greater carotid intima-media thickness, an indicator of the early stages of atherosclerosis.

By Liz Highleyman

Previous research has found that people with chronic hepatitis C virus (HCV) infection have an elevated risk for cardiovascular disease. While HCV has been linked to insulin resistance or diabetes -- known risk factors for heart disease -- it is also typically characterized by favorable blood lipid levels.

In the present study, Aya Mostafa from AinShams University in Cairo and colleagues looked at the effect of this paradoxical risk profile on metabolism and atherosclerosis (hardening of the arteries and build-up of plaque) in the setting of HCV infection and clearance.


This cross-sectional analysis included more than 1200 participants in Egypt aged 35 years or older. Within this study population, 329 had chronic hepatitis C, 173 had cleared HCV infection, and 795 were never infected with HCV; a subset of 192, 115, and 187 participants, respectively, from the 3 groups underwent ultrasound imaging.

The investigators evaluated presence of diabetes, fasting blood glucose, lipid levels, and body fat deposition using ultrasound. Carotid intima-media thickness (IMT), or width of the inner lining of the carotid arteries supplying the brain, was used as a measure of atherosclerosis.

Results
  • Diabetes was more common among participants with chronic hepatitis C and cleared HCV infection (both with a prevalence of 10.1%) than among those who never had HCV (6.6%; P = 0.04 for chronic, 0.08 for cleared).
  • The amount of mesenteric or visceral fat was greater in people with chronic hepatitis C (36.4 mm) and cleared infection (37.8 mm) relative to those never infected (32.7 mm; P = 0.004 for chronic, < 0.0001 for cleared).
  • Low-density lipoprotein (LDL) cholesterol levels were lower in the chronic hepatitis C group (2.69 mmol/L; P < 0.001), but similar in those with cleared infection (3.56 mmol/L; P = 0.4) and those never infected (3.45 mmol/L).
  • Carotid IMT did not differ significantly according to HCV infection status, at 0.73, 0.71, and 0.71 mm, respectively.
  • After adjustmenting for traditional cardiovascular risk factors, however, IMT was greater in peoplewith chronic infection (0.76 mm) compared with never infected individuals (0.70 mm; P = 0.02).
Based on these findings, the researchers proposed, "Hepatic function normalization with HCV clearance may account for reversal of favorable lipids observed with HCV infection." However, they added, glucose levels and visceral fat accumulation "appear less amenable to HCV resolution."

"These different cardiovascular risk patterns may determine equivalent atherosclerosis risk by infection status," they suggested. "However, once these factors were accounted for, those with chronic infection had raised IMT, suggesting a direct effect of infection."

Department of Community Medicine, Faculty of Medicine, AinShams University, Cairo, Egypt; Department of Tropical Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt; Viral Hepatitis Reference Laboratory, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; Institut Pasteur, Paris, France; Department of Metabolic Medicine, Imperial College NHS Healthcare Trust, London, UK; International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College NHS Healthcare Trust, London, UK; Faculty of Medicine, Minia University, Minia, Egypt.

7/30/10

Reference

A Mostafa, MK Mohamed, M Saeed, and others. Hepatitis C infection and clearance: impact on atherosclerosis and cardiometabolic risk factors. Gut (Abstract). June 28, 2010 (Epub ahead of print).

Source

Organ donor shortage makes survival a long shot

 By Sandra V. Rodriguezsrodriguez@citizen-times.com • July 30, 2010

ASHEVILLE — Julie Wallace always said yes to organ donation.

But in recent years, the little heart on her driver's license has held deeper meaning because she came so close to losing her 12-year-old son, Jacob. Both of his kidneys failed nine years ago, when Jacob was 3.

“It was a nightmare,” she said. “I literally just prayed every night that he would make it. It's a rough thing when you're waiting for a transplant for a loved one because you know that someone else's loved one has to pass away…”

That someone was a woman who suffered a fatal aneurysm while exercising. She left behind children and a husband, who consented to donate her organs. The woman gave at least seven people a second chance at life.

There are more than 3,300 North Carolinians included in the transplant waiting. Unfortunately for many, the number of donors isn't keeping up.

Kirk Truesdale was diagnosed with hepatitis C five years ago, but doctors didn't catch it in time to save his liver. Truesdale has been on the transplant waiting list for nearly three years. At one time, he was moved to hospice care because of how sick he became. His wife, Shirley, even began making funeral arrangements.

“A lot of people don't understand the things that you go through when you're waiting for a transplant,” Shirley said. “You're dealing with a very sick person that if you let yourself think about a lot, you'll feel like the sand is running out in the glass.”

Truesdale knows his sickness is harder on his wife and 12-year-old daughter, Keeley, than it is on him. The ammonia buildup in the one-time ironworker's body often leads to his legs or belly swelling up with fluid. This causes what Shirley describes as Alzheimer's-like behavior in Truesdale, who can get combative or ramble endlessly or wander off during these spells.

“It's been hell,” he said. “There are times when you want to just say to God, ‘Just take me.'”

The state has made strides to increase donor registration in recent years by making it easier to register in person at the Department of Motor Vehicles or online or at DonateLifeNC.org, and passing the Heart Prevails law in 2007. It turned the heart on the driver's license from a symbol of intent to donate to legal consent for organ and eye

“In the past, I think people realized it didn't mean a whole lot because they knew the family could override it,” Melissa Parker, organ procurement specialist with LifeShare of the Carolinas' office in Asheville. The nonprofit provides tissues and organs for transplantation for people in southwestern North Carolina. “But now that heart means something.”

Parker has worked with donors for the last 15 years, and she's never seen the waiting list numbers go down. When she first started doing this job, there were about 30,000 people on the waiting list, and now it's nearly 108,000. The list increases by one every 12 minutes, according to Carolina Donor Services.

The situation is especially critical for kidney transplants for minorities who make up “disproportionately” high number of people on the waiting list, said Debbie Gibbs, with LifeShare in Charlotte.

It's largely because of high blood pressure and diabetes, which are more common in the African-American, Hispanic and Native American communities.

In North Carolina, 60 percent of the kidney transplant waiting list is made up of African-Americans as opposed to 35 percent nationwide. The state's donor rate for African-Americans was 26 percent in 2009.

Generally, Parker said race does not play a role in who gets an organ transplant. For any transplant, the most important factor is always blood type. But it would be best, in cases of kidney or pancreas transplants, that a person received the organ from someone who has similar tissue, she said.

“We never think that someone in our family or one of our close friends is going to need a transplant,” Wallace said. “He (Jacob) was born a completely healthy child, and some freak illness caused him to be very ill. He would have died, absolutely, at age 5 had we not gotten his transplant.”

Even now, eight years after the “nightmare” ended, the fear and worry are never far. Wallace still gets anxious when Jacob shows signs of fever.

That's something new parents Larry and Meghan Robertson understand intimately. The couple's 7-month-old baby, Ty, was born without a right kidney, and the left one is only one-third its normal size. The doctors had very little hope that he would make it. It was devastating news for the couple, who had spun so many dreams in the last nine months.

“It's not what any mother looks for when she says, ‘I'm pregnant,'” Meghan said. “I didn't think about my baby being in NICU (neonatal intensive care unit) and going through all this.”

While families everywhere were waiting for Santa, Meghan spent last Christmas Eve in a Winston-Salem hospital praying that her baby would make it through the night.

But what a difference a few months makes. With the help of a dialysis machine, 7-month-old Ty has shown strength of will that makes his parents hopeful that he will hold on long enough to get on the national organ transplant waiting list.

It's hard to tell how long the wait will be for Ty once he gets on the list. He needs to weigh 22 pounds before that happens. But the Robertsons' family and friends are hoping to speed the process along by getting tested to see if there is a match.

“I want to see him grow up,” Meghan said. “I want to see him go to school. Go to college. Get married and have my grandbabies. I want to see all that, and I hope that he is more than able to do it.”

Source

4 vets positive for hepatitis after St. Louis clinic visit

ST. LOUIS — Four veterans treated at the St. Louis VA Medical Center's dental clinic have tested positive for hepatitis, but further testing is needed to determine if inadequately sterilized dental equipment is to blame.

The Veterans Administration provided test results on Friday to The Associated Press.

The VA last month sent letters to 1,812 veterans treated at the clinic from Feb. 1, 2009, through March 11, 2010, urging them to take blood tests because the cleaning errors could have exposed them to hepatitis B, hepatitis C or HIV.

The VA says the risk of infection is remote.

The VA says 1,022 veterans have been tested and notified of results. Of those, two tested positive for hepatitis B, two tested positive for hepatitis C, and none tested positive for HIV.

Copyright 2010 The Associated Press.

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