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ScienceDaily: Your source for the latest research news

Hepatitis C treatment cures over 90 percent of patients who also have cirrhosis

Date:
April 12, 2014
Source:
University of Texas Health Science Center at San Antonio
Summary:
Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to a new study.

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute. Historically, hepatitis C cure rates in patients with cirrhosis (liver scarring) have been lower than 50 percent and the treatment was not safe for many of these patients.

Hepatitis C virus is the No. 1 driver of cirrhosis, liver transplants and liver cancer in the United States, noted Fred Poordad, M.D., lead author on the study, which was released Saturday by The New England Journal of Medicine in conjunction with Dr. Poordad’s presentation of the data at the International Liver Congress in London. UT Medicine is the clinical practice of the School of Medicine at The University of Texas Health Science Center at San Antonio, where Dr. Poordad is a professor of medicine. He is vice president of the Texas Liver Institute in San Antonio.

Interferon previously was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents — ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin. Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8 percent of patients who took the pills for 12 weeks. Among patients treated for 24 weeks, 95.9 percent were virus-free 12 weeks after the end of therapy.

 

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 Combination Drug Therapy Amazingly Effective In Tackling Hepatitis C

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ScienceDaily: Your source for the latest research news

 

New combination drug therapy proves very effective in hepatitis C treatments

Date:
April 12, 2014
Source:
Beth Israel Deaconess Medical Center
Summary:
Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

A new 12-week single tablet regimen of ledipasvir and sofosbuvir have proven to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections, according to results unveiled today at the European Association for the Study of the Liver and published simultaneously online by the New England Journal of Medicine.

Between 94 percent and 99 percent of patients were cured of hepatitis C and results were similar in patients who have never been treated and for those who had previously been treated with a combination of peginterferon and ribavirin, the current course that carries sometimes significant side effects.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection and to provide an option for patients who are ineligible for the current interferon-based treatments,” said Nezam Afdhal, MD, the senior author of the studies, Director of the Liver Center at Beth Israel Deaconess Medical Center and a Professor of Medicine at Harvard Medical School.

Hepatitis C is an infectious disease primarily affecting the liver and which can lead to scarring and cirrhosis and is transmitted primarily through blood transfusions (prior to 1991), intravenous drug use, poorly sterilized medical equipment and sexual transmission.. After exposure 80 percent of patients develop a chronic hepatitis which can lead to cirrhosis, liver failure and liver cancer and hepatitis C is the most common cause for liver transplantation in the US.

Prior treatments have been with interferon which is an injectable cytokine released in response to viral infections. Interferon is combined with other antiviral agents and needs to be used for up to 48 weeks to cure hepatitis C. but is associated with number of side effects, including influenza-like symptoms depression and anemia. Many patients are ineligible for these interferon-based therapies.

“The real advances seen in the Ion trials is that the sofosbuvir-ledipasvir combination tablet enables us to treat almost all genotype 1 patients with a short duration of 8-12 weeks of treatment expanding the treatment pool and increasing the overall cure rate,” said Afdhal.

Recent recommendations by the CDC and endorsed by the USPHS Task force have recommended screening of baby boomers (persons born between 1945 and 1965) for hepatitis C since up to3 percent may have silent infection without symptoms.
“Screening for HCV needs to be associated with a safe and effective treatment for these “baby boomers” with newly identified HCV and the ION trials clearly give an exciting new option for these patients” stated Afdhal.

 

 

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Kitchen Cutting Boards Harbor Antibiotic-Resistant Bacteria

A new study published in the Journal Infection Control and Hospital Epidemiology found that kitchen cutting boards can become contaminated with antibiotic-resistant bacteria from raw meat. Researchers at the University Hospital in Basel, Switzerland looked at 154 cutting boards before they were washed from the hospital and 44 from private homes after they were used to prepare pork, beef, veal, lamb, game, or fish. In addition, kitchen gloves worn during meat preparation were tested.

Cutting BoardThe scientists discovered that 6.5% of the hospital cutting boards and 3.5% of the household cutting boards used to prepare poultry tested positive for “multidrug-resistant E. coli bacteria.” None of the boards used for meat other than poultry dated positive. Fifty percent of the gloves were contaminated with multidrug-resistant E. coli.

 

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Eating Carotenoid-Rich Vegetables May Improve Your Breast Health



Eating vegetables rich in carotenoids — like kale, spinach, melons, and yams — can prevent benign breast disease, and possibly breast cancer through their antioxidant properties, a new study found.

The lead researcher, Caroline Boeke, told HealthDay that plenty of studies have examined the effects of fruits and vegetables (and their carotenoids) on breast health. Most of them have produced mixed results; but in general they suggest that carotenoids, which are a type of pigment found in orange, red, or green vegetables, have a positive effect on breast health. Benign breast disease may involve a form of noncancerous breast condition, which may play a role in raising the risk of breast cancer.

The researchers examined girls in an ongoing study since 1996, reviewing their food reports from 1996 to 1998 then doing evaluations in 2005, 2007, and 2010 among the girls who received a benign breast disease diagnosis. There were 6,600 girls who participated in the study, with 122 that had a benign breast diagnosis.

 

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California Warns Consumers Not to Eat Anchovies, Sardines, Crab

The California Department of Public Health is warning consumers not to eat commercially or recreationally caught anchovies or sardines or the internal organs of crab from Monterey and Santa Cruz counties. Dangerous levels of domoic acid have been found in some of these species and could be found in other species.

AnchoviesDomoic acid is produced by phytoplankton, a type of algae, and accumulates in shellfish, sardines and anchovies. It is a biotoxin that affects the brain. Several people have died over the years and may others have become permanently disabled with brain damage after eating domoic acid contaminated seafood. The first reported outbreak of domoic acid poisoning was in 1987 at Prince Edward Island, Canada. Three people died and more than 100 were sickened in that outbreak after eating contaminated seafood.

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SFGate

State issues warning over toxic seafood

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Sardines are among the species of fish health officials are warnign could be tainted with domoic acid. (Photo: San Francisco Chronicle)

 

State officials are advising consumers to stay away from certain types of seafood caught in the waters off Monterey and Santa Cruz counties after a toxic chemical was detected in some of the fish.

The California Department of Public Health issued the warning Thursday, telling the public to avoid sardines, anchovies and the internal organs of crabs because some samples from the region tested positive for domoic acid.

Domoic acid typically resides in the digestive tracts of the fish.

Symptoms of domoic acid poisoning usually set in between 30 minutes to 24 hours after eating tainted seafood and can include nausea, headaches, dizziness, diarrhea and abdominal cramps. Severe cases can cause trouble breathing, loss of short-term memory, coma or death.

 

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Shellfish Irradiation To Reduce Food Poisoning Gets FDA Nod

The U.S. Food and Drug Administration has approved the use of ionizing radiation to kill foodborne pathogens on crustacean shellfish and extend their shelf life. The April 11 decision is in response to a food additive petition submitted by the National Fisheries Institute 13 years ago.

irradiated-symbolThe decision will allow processors of crustaceans including crab, shrimp, lobster, crayfish, and prawns use small amounts of ionizing radiation to reduce, but not eliminate, dangerous foodborne bacteria such as E.coli, Vibrio and Listeria.  The maximum permitted dose is 6.0 kiloGray.

The rule covers shellfish sold raw, frozen, shelled, dried, cooked and partially cooked. It also covers crustaceans processed with spices or a small number of other ingredients.

 

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Forbes

Will Irradiated Burgers Turn You Radioactive? The Truth About Food Irradiation

As prolific and commonplace as they are in our lives, “foodstuffs” and “food processes” still confound us. I recently received a query in my inbox; the sender was anxious over some irradiated burgers he had bought. Would they harm him? Would they turn him radioactive? Upon reflection, it seemed ripe fodder for a Forbes post.

I noticed a symbol on a package of burgers that I bought, and saw that it meant the beef had been irradiated. I didn’t eat them. What does this mean to have food irradiated, what does involve, is it bad for me, and were the burgers radioactive?

Radiation at the best of times doesn’t elicit warm, fuzzy feelings. When it gets anywhere near our food supply, we’re prone to panic, hysteria even. But, with irradiated food, where the results are comparable to pasteurization, there’s absolutely no need for frenzy, or to let perfectly fine fare go to waste.

While conventional pasteurization depends on heat, irradiation relies on energy generated by ionizing radiation. This can come from either gamma rays from a radioactive element like cobalt-60, electron beam technology or x-rays. Higher doses of irradiation can kill disease-causing microorganisms like E.coli and Salmonella – this would have been the case with your burgers. Lower doses can replace other forms of fumigation to eradicate insects such as fruit flies and weevils from produce, and extend shelf life by retarding spoilage and natural processes such as ripening and sprouting.

All irradiated food is required by law to carry an internationally recognized symbol, known as a radura — usually green and resembling a circular flower flanked by two leaves within a broken circle. The packaging must also bear a statement indicating the food has been irradiated.

The radura should embolden you to tuck in rather than to throw out your burgers. Irradiation is by no means intended as a substitute for scrupulous hygiene standards, but it does provide that extra measure of safety. The off-putting reality is that burgers and other ground meat products are prone to contamination being frequently made from off-cuts and trimmings that may have been in contact with fecal matter. If a single cut of meat, say a steak or a chicken breast, is contaminated with E.coli or Salmonella, the pathogens harbor only on the surface of the meat being unable to permeate to the interior. Searing the outside over high heat will kill off any nasties. With a burger however, surface bacteria can become mixed into the ground meat. The risk of food poisoning then is inordinately higher despite a well-browned crust  - especially if you like your burgers pink and well below 160F in the middle.

 

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US News & World Report

The Basics on the Foodfight Over Irradiation

Should you look for the “radura” symbol?

Video: Healthful Eating Recipes

Video: Healthful Eating Recipes

By Sept. 5, 2008 SHARE

The Food and Drug Administration’s approval late last month of pathogen-zapping irradiation technology for fresh spinach and iceberg lettuce has reignited a long simmering debate about how to improve the safety of food. The news comes as the latest food safety scare—the salmonella outbreak probably caused by hot peppers—winds down after infecting 1,442 people across 43 states and killing two of them. The Centers for Disease Control estimates that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year in the United States.

Given the less than spotless state of the nation’s food supply, is bombarding a product with radiation to kill microorganisms such as E. coli and salmonella a good thing? Or should you avoid irradiated food, as some groups urge? U.S. News asked food safety experts some key questions to help you decide.

What is irradiation?
The process involves treating a food with a short burst of high energy radiation that damages the DNA of bacteria. Though the FDA has only just approved the technique for use with fresh spinach and iceberg lettuce, the technology is not new. In fact, the agency has conducted safety tests on the technology for more than 40 years, and its use on meat has been approved since 1997. Spinach and iceberg lettuce are the first types of produce approved for irradiation at levels intense enough to kill pathogens. (Lower doses have been approved for other purposes, such as controlling insect infestations and slowing ripening produce’s maturation.) Why do some food processors want to irradiate food?
Groups that represent food processors, such as the Grocery Manufacturers Association and the American Meat Institute, want to irradiate certain products to kill problematic pathogens and to extend shelf life. Research shows that irradiation destroys 99.9 percent of common foodborne pathogens. However, advocacy groups such as Food & Water Watch and the Organic Consumers Association oppose the irradiation of food on the grounds that it doesn’t address the root causes of outbreaks, such as unsanitary conditions at farms and food processing plants, and reduces the nutritional quality, taste, and texture of food. Why has the Food and Drug Administration decided to approve the technology for use with spinach and lettuce now?

 

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FDA Expands Irradiation of Food Supply; Harmonizing with Codex Alimentarius

Brandon Turbeville
Activist Post

Demonstrating the lack of concern held by regulatory agencies for public safety or public opinion as well as the increasing attempts to become compliant with Codex Alimentarius regulations, the FDA has recently expanded the amount of ionized radiation that can be used to treat unrefrigerated raw meat.

As reported by Food Safety News, the two new policies decided upon by the FDA were issued in response to two petitions filed in 1999 by the Food Safety and Inspection Service of the U.S. Department of Agriculture.

While the previous policy was that only refrigerated or frozen meats could be irradiated, the new rule allows for the irradiation of unrefrigerated raw meat. The second rule change allows for increasing the dose of ionizing radiation in poultry from 3.0 kGY to 4.5 kGy.

Although a period for public comment is always set aside for regulatory agency decisions regarding potential changes to policy, the FDA promptly ignored the many comments it received from individuals all over the country as well as consumer advocacy groups which requested the denial of the two FSIS petitions.

The response from the FDA was that all of these comments, made by individuals and by groups such as Public Citizen and the Center for Food Safety, “were of a general nature” and “did not contain any substantive information that could be used in a safety evaluation of irradiated poultry.” This statement was made regarding both the poultry irradiation rule and the passage of a new meat temperature rule.

Predictably, the FDA has defended its decision by circular logic that flies in the face of science and common sense. The agency is claiming that “irradiating unrefrigerated meat was not found to increase meat’s toxicity, change the food’s nutritional properties or increase the likelihood of certain bacteria thriving on meat; therefore FDA has determined that this is a safe application for the process.”

Of course, while the FDA claims that irradiation is not found to increase toxicity or change nutritional properties, the very reason that the FDA has jurisdiction over food irradiation to begin with is because the process of irradiation can do just these very things. Even the FDA admits[1] that, because irradiation “can affect the characteristics of the food,” it is considered a “food additive.” Thus, because food additives fall under the purview of the FDA, irradiation is regulated (or not) by the agency.

By allowing for higher doses of irradiation in food, the FDA is knowingly complicit in covering up unsanitary food production practices by major corporations as well as accepting the inclusion of clearly harmful material (i.e. radiation) into the food supply. Keep in mind, irradiation is mostly used by corporations in order to cover up deplorable manufacturing conditions and dangerous food contamination.

 

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Food Irradiation Supports Agribusiness, Harms Health

Irradiation Lab Mouse Food Irradiation Supports Agribusiness, Harms Health

 

by Heidi Stevenson
Gaia-Health.com

Agribusiness is polluting and destroying the food on which we depend . Irradiation destroys nutrients and creates poisons. Despite claims, it’s largely hidden from us. It exists for the benefit of Agribiz, not for our health.

Food irradiation exists only because Agribusiness exists. It isn’t to support your health. As we’ve seen recently with outbreaks of food-borne disease, modern food production is innately unhealthy. It utilizes monoculture, long term storage, and chemicals. None of these are good for us, but all create enormous profits for a money-hungry industry. The need to sterilize foods on a mass scale simply did not exist until Agribusiness changed the nature of what we eat.

Modern food processing and distribution is highly mechanized, with tremendous pressure placed on employees to simply push things through and money carefully spent to grease the palms of those who might have called a stop to the madness. Agribusiness considers it cost-effective to irradiate foods, which sterilizes them and significantly increases their shelf life.

The efforts to utilize irradiation cover the spectrum from propaganda to hiding it from the public. We’re told that food irradiation is safe, effective, and doesn’t affect food quality. Let’s call these claims the myths that they are and examine them.

Myth: Irradiation is effective.

Fact: This is a very slippery claim. Yes, it does kill many infectious organisms, in particular, bacteria. However, it does not protect against toxic elements, such as the neurotoxin produced by Clostridium botulinum, the bacterium that causes botulism. Killing the bacteria can create a sense of security, though the actual disease cause is still present.

Irradiation’s effectiveness against viruses is limited, so anthrax and hepatitis may still survive after irradiation. Prions, the cause of mad cow disease, are untouched by it.

Reinfestation of food is not prevented by irradiation. In fact, it holds the potential of allowing worse contamination. By eliminating most infectious organisms, beneficial ones are also destroyed. This results in there being nothing to prevent reinfection, allowing opportunistic bacteria and viruses free rein in irradiated foods.

Factory farms are not healthy places. Pigs are kept for their entire lives in horrifically unsanitary conditions, with their droppings and urine left uncleared where they fall through the cages, so they rot and release constant toxic fumes. Irradiation is a means to avoid dealing with this inhumane and unhealthy situation.

Urine, feces, pus, tumors, and vomit are not removed by irradiation.

Myth: Irradiation is safe.

Fact: This is simply false. As documented in Food Irradiation, Cats, and Doublespeak: Researchers Reinvent Reality, it’s well known to cause neurological damage in cats.

Irradiation generates furans in food. Carbofuran is a member of this class. It’s the poison, which is banned in Europe and severely curtailed in the US, that FMC sells under the name of Furadan, as reported in PsychoCorp #1—FMC Product Banned in U.S. Kills Lions in Africa. All furans are considered carcinogenic. Fruits, in particular, are affected by the generation of furans.

Public Citizen reports laboratory animals fed irradiated foods suffered “a myriad of serious health problems in laboratory animals that ate irradiated foods, including premature death, fatal internal bleeding, a rare form of cancer, stillbirths and other reproductive problems, mutations and other genetic damage, organ malfunctions, stunted growth and vitamin deficiencies.”

The growth of aflatoxin, implicated in liver cancer in southern states, is stimulated by irradiation. The World Health Organization considers aflatoxin to be a significant health risk. Unique Radiolytic Products (URPs) are produced by irradiation. These chemical compounds have not been well studied, but one group of them, cyclobutanones, have been found to promote cancer and genetic damage in rats, and to cause genetic and cellular damage in both rats and humans. Cyclobutanones are radiation by-products of palmitic acid, which is present in nearly all foods.

Other chemicals known to cause cancer and birth defects are formed by irradiation, including benzene, toluene, and methyl ethyl ketone.

Free radicals are formed by irradiation. These are the targets of antioxidants, supplements that are very popular now. Consider that some antioxidants, such as vitamin A, are destroyed by irradiation. So irradiation holds a double whammy against health—destroying the antioxidants that might help resolve the chemicals it creates.

The journal, Nutrition and Cancer reported in 2002 that colon cancer can be caused by a chemical compound found only in irradiated food.

Myth: Irradiation doesn’t affect food quality.

Fact: There is extensive documentation for the loss of key nutrients from irradiation of food. The Center for Food Safety reports that anywhere from 2-95% of the vitamins can be lost. They cite losses of as much as 80% of vitamin A in eggs, 95% of vitamin A and lutein in green beans, 50% of vitamin A and lutein in broccoli, and 40% of beta carotene in orange juice. Irradiation is also reported to destroy the B, C, E, and K vitamins.

 

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Additional Sources on Irradiation of food and it’s byproducts

Pubmed Data : Nutr Cancer. 2002;44(2):189-91. PMID: 12734067
Study Type : Animal Study

Pubmed Data : J Food Prot. 2008 Jun;71(6):1270-2. PMID: 18592759
Study Type : Animal Study

Pubmed Data : Poult Sci. 2001 Jan ;80(1):105-8. PMID: 11214329
Study Type : Animal Study

Pubmed Data : Food Chem Toxicol. 2012 Sep 19 ;51C:46-52. Epub 2012 Sep 19. PMID: 23000443
Study Type : Animal Study

Pubmed Data : Neurosci Lett. 2006 Sep 25;405(3):172-4. Epub 2006 Jul 26. PMID: 12380747
Study Type : Animal Study
Additional Links

Additional Keywords : Gamma Irradiation : CK(9) : AC(6)

Pubmed Data : Biosci Biotechnol Biochem. 2012 ;76(5):900-5. Epub 2012 May 7. PMID: 22738956
Study Type : Plant Study

Pubmed Data : PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):432-5. PMID: 21502047
Study Type : Review

Pubmed Data : J Agric Food Chem. 2005 Oct 5;53(20):7826-31. PMID: 16190637
Study Type : In Vitro Study
Additional Links

Additional Keywords : Gamma Irradiation : CK(9) : AC(6)
Problem Substances : Furan : CK(11) : AC(2)
Adverse Pharmacological Actions : Carcinogenic : CK(936) : AC(130)

Pubmed Data : J Sci Food Agric. 2011 Mar 15;91(4):634-49. Epub 2010 Dec 23. PMID: 21302317
Study Type : In Vitro Study
Additional Links


Pubmed Data : J Food Sci. 2011 Sep ;76(7):C1056-61. PMID: 22417543
Study Type : Plant Study
Additional Links

Pharmacological Actions : Antioxidants : CK(3723) : AC(1318)
Adverse Pharmacological Actions : Oxidant : CK(104) : AC(37)

Pubmed Data : Poult Sci. 2011 Nov ;90(11):2578-83. PMID: 22010244
Study Type : Review

Pubmed Data : Food Chem Toxicol. 2007 Dec;45(12):2581-91. Epub 2007 Jun 28. PMID: 17766022
Study Type : In Vitro Study
Additional Links

Additional Keywords : Gamma Irradiation : CK(9) : AC(6)

Pubmed Data : Mutat Res. 2006 Feb 22;594(1-2):10-9. Epub 2005 Sep 8. PMID: 16153665
Study Type : In Vitro Study

 

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Food Poisoning Bulletin

Hepatitis A Exposure at Restaurant in Nyack, NY

Seems like it’s the season for hepatitis A. A confirmed case of acute hepatitis A has been identified in a food handler at the La Fontana restaurant in Nyack, New York. Anyone who ate there between March 19 and April 1, 2014 may have been exposed to hepatitis A.

Hepatitis A Virus

 

The County of Rockland Department of Health is recommending that everyone who ate at the restaurant on March 29, March 30, or April 1, 2014 receive a vaccination. The vaccination is about 80% to 90% effective. The Rockland County Department of Health is offering free vaccines to patrons and employees of the restaurant on Sunday, April 13, 2014 from 11:00 am to 3:00 pm and Monday, April 14, 2014 from 9:00 am to 12:00 pm at the Rockland County Fire Training Center at 35 Firemens Memorial Drive in Pomona.

 

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NY eatery patrons possibly exposed to hepatitis

April 12

The Associated Press

— Health officials say a waiter at a popular Rockland County restaurant may have exposed hundreds of patrons to hepatitis A.

The Journal News reports (http://lohud.us/1hqzs4V ) that the waiter may have exposed customers at La Fontana in Nyack to the disease between March 19 and April 1.

People who ate at the restaurant March 29 through April 1 can get a free hepatitis vaccine Saturday through Monday at the Rockland Fire Training Center in Ramapo.

 

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La Fontana waiter may have exposed hundreds of patrons to hepatitis A, health officials say

Health officials say a waiter at a popular Rockland County restaurant may have exposed hundreds of patrons to hepatitis A.

The Journal News reports that the waiter may have exposed customers at La Fontana in Nyack to the disease between March 19 and April 1.

People who ate at the restaurant March 29 through April 1 can get a free hepatitis vaccine Saturday through Monday at the Rockland Fire Training Center in Ramapo.

 

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Mercola.com

Sleep Loss May Cause Brain Damage and Accelerate Onset of Alzheimer’s, Two New Studies Show

 

By Dr. Mercola

Could poor sleeping habits cause brain damage and even accelerate onset of Alzheimer’s disease? According to recent research, the answer is yes on both accounts.

According to neuroscientist Dr. Sigrid Veasey, associate professor of Medicine and a member of the Center for Sleep and Circadian Neurobiology at the Perelman School of Medicine, this is the first time they’ve been able to show that sleep loss actually results in the loss of neurons.

A second study also suggests that if you sleep poorly, you’re at increased risk for earlier onset of severe dementia.

Sleep Loss Linked to ‘Massive Brain Damage’

The first study in question, published in the Journal of Neuroscience,1, 2, 3 found that sleep is necessary for maintaining metabolic homeostasis in your brain. Wakefulness is associated with mitochondrial stress, and without sufficient sleep, neuron degeneration sets in.

The research also showed that catching up on “sleep debt” on the weekend will not prevent this damage. To reach their conclusion, the researchers submitted mice to an irregular sleep schedule similar to that of shift workers.

Inconsistent, intermittent sleep resulted in a remarkably considerable, and irreversible, brain damage—the mice actually lost 25 percent of the neurons located in their locus coeruleus,4 a nucleus in the brainstem associated with arousal, wakefulness, and certain cognitive processes. As reported by Time magazine:5

“The scientists believe that when the mice slept inconsistently, their newer cells would create more sirtuin type 3, a protein meant to energize and protect the mice. But after several days of missing sleep, as a shift worker might, the protein creation fell off and cells began to die off at a faster pace.”

Chronic Sleep Disruption May Trigger Alzheimer’s Onset

In a similar vein, research published in the journal Neurobiology of Aging6 suggests that people with chronic sleep problems may develop Alzheimer’s disease sooner than those who sleep well. According to lead author Domenico Praticò, professor of pharmacology and microbiology/immunology in the university’s School of Medicine:7

“The big biological question that we tried to address in this study is whether sleep disturbance is a risk factor to develop Alzheimer’s or is it something that manifests with the disease.”

Using mice bred to develop Alzheimer’s, the researchers exposed one group of mice to 12 hours of light and 12 hours of darkness, while another group was exposed to 20 hours of light and only four hours of darkness. This lack of darkness significantly reduced the amount of time the mice slept.

At the end of the eight-week long study, the mice that slept less were found to have significantly poorer memory. Their ability to learn new things was also impaired—despite the fact that the two groups of mice had about the same amount of amyloid plaque (a hallmark of Alzheimer’s) in their brains. According to Dr. Praticò:

“[W]e did observe that the sleep disturbance group had a significant increase in the amount of tau protein that became phosphorylated and formed the tangles inside the brain’s neuronal cells…

Because of the tau’s abnormal phosphorylation, the sleep-deprived mice had a huge disruption of this synaptic connection. This disruption will eventually impair the brain’s ability for learning, forming new memory and other cognitive functions, and contributes to Alzheimer’s disease.”

Since both groups of mice were bred to develop Alzheimer’s but the sleep deprived group developed these dementia-related problems sooner than the others, the researchers believe that poor sleep acts as a trigger of pathological processes that accelerate the disease. The researchers concluded that “chronic sleep disturbance is an environmental risk factor for Alzheimer’s disease.”

Previous research, published in the journal Science,8 has also revealed your brain removes toxic waste during sleep through what has been dubbed “the glymphatic system.”9, 10, 11, 12, 13 This system ramps up its activity during sleep, thereby allowing your brain to clear out toxins, including harmful proteins linked to brain disorders such as Alzheimer’s.

By pumping cerebral spinal fluid through your brain’s tissues, the glymphatic system flushes the waste, from your brain, back into your body’s circulatory system. From there, the waste eventually reaches your liver, where it’s ultimately eliminated. So it’s quite likely that sleep affects your brain function and your risk of degenerative diseases such as Alzheimer’s in more ways than one.

Elderly Women Are Twice as Likely to Develop Alzheimer’s Than Breast Cancer

Being aware of the links between sleep and Alzheimer’s onset may be particularly important for women, as they are at greatest risk for the disease.14 According to the 2014 Facts and Figures report issued by the Alzheimer’s Association,15 women over the age or 60 have a one-in-six chance of developing Alzheimer’s—nearly double the risk of men, who have a one-in-11 chance. Even more disturbing, a woman’s chance of developing Alzheimer’s is twice as great as her risk of developing breast cancer!

Since there’s no cure, and no truly effective treatments, taking steps to prevent Alzheimer’s becomes paramount. And it seems clear that sleeping properly is one important factor to take into consideration. For more information about Alzheimer’s prevention, please see my previous article “How to Prevent Alzheimer’s Disease—A Neurologist Speaks Out.”

 

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Prostate cancer tests underestimate aggressiveness of disease, says study

 

A surgeon sitting in front of screens of a Focal One device performs a prostate tumorectomy.

A surgeon sitting in front of screens of a Focal One device performs a robot-assisted prostate tumorectomy. Photograph: Jeff Pachoud/AFP/Getty Images

Men with prostate cancer are being given false hope by tests that underestimate the aggressiveness of their disease, according to a study.

Researchers found that more than half of a group of men whose cancers were initially classified as slow-growing and confined later turned out to have more dangerous tumours.

The findings, published in the British Journal of Cancer, call into question the ability of experts to grade and stage prostate cancers on the basis of biopsy samples.

It also casts doubt on the “active surveillance” strategy of avoiding unnecessary radical treatment for patients with slow-growing prostate cancer.

Instead, these patients are closely monitored but left alone until tests suggest their condition has worsened.

Urological surgeon Greg Shaw, from the Cancer Research UK Cambridge Institute, said: “Our results show that the severity of up to half of men’s prostate cancers may be underestimated when relying on tests before they have surgery.”

Slow-growing prostate cancers, known as “pussycats”, are very different from the more aggressive “tiger” variety.

In some cases, especially when he is older when diagnosed, a patient can live to the end of his normal life span before a “pussycat” cancer becomes a threat.

An aggressive “tiger”, on the other hand, may quickly spread if it is not surgically removed or destroyed.

Biopsy samples examined under a microscope are used to rate prostate tumour aggressiveness with a score ranging from two to 10. A score of between two and six is a low-grade “pussycat”. A score of seven is intermediate, while scores of eight to 10 are high-grade “tigers”.

Tumours are also staged according to how far they have spread. A T2 tumour is contained completely inside the prostate gland, while a T3 tumour has started to break out, and one classified T4 has spread to other organs or sites in the pelvic cavity.

The Cambridge scientists compared the staging and grading of more than 800 men’s cancers before and after they had surgery to remove their prostate.

They found that of 415 patients whose cancer was classified as slow-growing and confined to the prostate, just over half (209) were found to have a more aggressive disease than originally thought when assessed after surgery.

 

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What the Tamiflu saga tells us about drug trials and big pharma

We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

Tamiflu capsules

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

Tamiflu being made by Roche The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That’s not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche’s proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche’s demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn’t have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

Packets of Tamiflu Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient should be able to tell whether they’re getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients’ self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

 

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Row erupts over influenza drug Tamiflu

Tamiflu is on the World Health Organisation's 'essential medicines' list (Flickr: kanonn)

Tamiflu is on the World Health Organisation’s ‘essential medicines’ list (Flickr: kanonn)

Governments who stockpile the anti-flu medicine Tamiflu are wasting billions of dollars on a drug whose effectiveness is in doubt, according to a new study.

The row has drawn in the drugmaker Roche, as well as industry regulators and independent scientists. Supporters of Tamiflu says the review’s conclusions are flawed and insiste the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” says Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it says in a statement.

Tamiflu sales hit almost $3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

 

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