This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Listeria-contaminated salad from Dole Food kills one: CDC
The U.S. Centers for Disease Control and Prevention (CDC) said one person had died and 12 were hospitalized from a multi-state listeria outbreak linked to packaged salads produced by Dole Food in its facility in Springfield, Ohio.
The CDC said it received reports of the listeria outbreak from Indiana, Massachusetts, Michigan, New Jersey, New York and Pennsylvania, starting July 5.
Although an investigation into the recent listeria outbreak began in September, the source of the illnesses was not clear until January when tests linked it to packaged salad produced at the Springfield facility, CDC said on Friday.
There is no evidence to suggest that packaged salads produced at other Dole facilities in the United States are linked to the illness, the CDC added.
Dole notified the CDC on Thursday that it had stopped all production at the processing facility and was withdrawing all packaged salads produced at the facility, the agency said.
Dole Fresh Vegetables Inc said in a statement on Friday that products that are being withdrawn can be identified with a code beginning with the letter "A" in the upper right-hand corner of the package.
Other products, including fresh fruits and vegetables, as well as packaged salads from Dole's other facilities are not part of the withdrawal, the company said.
At least one outbreak of the life-threatening bacterial infection has been recorded every year since 2011, primarily linked to prepackaged foods and dairy products, according to the agency's website.
Listeriosis, caused by eating food contaminated with listeria, primarily affects older adults, pregnant women, newborns and adults with weakened immune systems.
Texas-based Blue Bell Creameries, ranked the No. 1 ice cream brand in the country in 2014, recalled all products last spring after a listeria outbreak in four states were linked to Blue Bell frozen treats. Three people died in the outbreak.
(Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian)
The mold that caused the September 5th recall of Chobani Greek yogurt may have consumers wondering if surface mold is a potential health threat.
According to the Associated Press, Chobani said the mold is not considered a foodborne pathogen and in most cases not a health risk to consumers. The company identified the mold as Mucor circinelloides, a type of mold that affects fruits and vegetables or other plants. Updates are available on the Chobani website.
Information For The Consumer
How many times have you pulled out a carton of strawberries only to find them covered with mold? Did you cut off the fuzzy growth and eat them anyhow? Oh no you didn't!
Provided below from the FDA's website is information describing a few dangerous molds, the health risk associated with mold found on refrigerated or purchased food, and a chart with instructions for handling moldy foods; when to use it, when to cut it off, and when to throw it away.
Molds On Food: Are They Dangerous?
Some molds cause allergic reactions and respiratory problems. And a few molds, in the right conditions, produce "mycotoxins," poisonous substances that can make people sick. When you see mold on food, is it safe to cut off the moldy part and use the rest? To find the answer to that question, delve beneath the surface of food to where molds take root.
What Are Molds?
Molds are microscopic fungi that live on plant or animal matter. No one knows how many species of fungi exist, but estimates range from tens of thousands to perhaps 300,000 or more. Most are filamentous (threadlike) organisms and the production of spores is characteristic of fungi in general. These spores can be transported by air, water, or insects.
Unlike bacteria that are one-celled, molds are made of many cells and can sometimes be seen with the naked eye. Under a microscope, they look like skinny mushrooms. In many molds, the body consists of:
root threads that invade the food it lives on,
a stalk rising above the food, and
spores that form at the ends of the stalks.
The spores give mold the color you see. When airborne, the spores spread the mold from place to place like dandelion seeds blowing across a meadow.
Molds have branches and roots that are like very thin threads. The roots may be difficult to see when the mold is growing on food and may be very deep in the food. Foods that are moldy may also have invisible bacteria growing along with the mold.
Are Some Molds Dangerous?
Yes, some molds cause allergic reactions and respiratory problems. And a few molds, in the right conditions, produce "mycotoxins," poisonous substances that can make you sick.
Are Molds Only on the Surface of Food?
No, you only see part of the mold on the surface of food — gray fur on forgotten bologna, fuzzy green dots on bread, white dust on Cheddar, coin-size velvety circles on fruits, and furry growth on the surface of jellies. When a food shows heavy mold growth, "root" threads have invaded it deeply. In dangerous molds, poisonous substances are often contained in and around these threads. In some cases, toxins may have spread throughout the food.
Where Are Molds Found?
Molds are found in virtually every environment and can be detected, both indoors and outdoors, year round. Mold growth is encouraged by warm and humid conditions. Outdoors, they can be found in shady, damp areas or places where leaves or other vegetation are decomposing. Indoors, they can be found where humidity levels are high.
Molds form spores which, when dry, float through the air and find suitable conditions where they can start the growth cycle again.
What Are Some Common Foodborne Molds?
Molds most often found on meat and poultry are Alternaria, Aspergillus, Botrytis, Cladosporium, Fusarium, Geotrichum, Monilia, Manoscus, Mortierella, Mucor, Neurospora, Oidium, Oosproa, Penicillium, Rhizopus and Thamnidium. These molds can also be found on many other foods.
What Are Mycotoxins?
Mycotoxins are poisonous substances produced by certain molds found primarily in grain and nut crops, but are also known to be on celery, grape juice, apples, and other produce. There are many of them and scientists are continually discovering new ones. The Food and Agriculture Organization (FAO) of the United Nations estimates that 25% of the world's food crops are affected by mycotoxins, of which the most notorious are aflatoxins.
What is Aflatoxin?
Aflatoxin is a cancer-causing poison produced by certain fungi in or on foods and feeds, especially in field corn and peanuts. They are probably the best known and most intensively researched mycotoxins in the world. Aflatoxins have been associated with various diseases, such as aflatoxicosis in livestock, domestic animals, and humans throughout the world. Many countries try to limit exposure to aflatoxin by regulating and monitoring its presence on commodities intended for use as food and feed. The prevention of aflatoxin is one of the most challenging toxicology issues of present time.
How Does the U.S. Government Control Aflatoxins?
Aflatoxins are considered unavoidable contaminants of food and feed, even where good manufacturing practices have been followed. The U.S. Food and Drug Administration and the USDA monitor peanuts and field corn for aflatoxin and can remove any food or feed with unacceptable levels of it.
Is Mushroom Poisoning Caused by Molds?
No, it is due to the toxin produced by the fungi, which are in the same family as molds. Mushroom poisoning is caused by the consumption of raw or cooked mushrooms, which are higher-species of fungi. There is no general rule of thumb for distinguishing edible mushrooms from poisonous toadstools. The toxins that cause mushroom poisoning are produced naturally by the fungi. Most mushrooms that cause human poisoning cannot be made safe by cooking, canning, freezing, or any other processing. The only way to avoid poisoning is not to eat poisonous mushrooms.
Are Any Food Molds Beneficial?
Yes, molds are used to make certain kinds of cheeses and can be on the surface of cheese or be developed internally. Blue veined cheese such as Roquefort, blue, Gorgonzola, and Stilton are created by the introduction of P. roqueforti or Penicillium roqueforti spores. Cheeses such as Brie and Camembert have white surface molds. Other cheeses have both an internal and a surface mold. The molds used to manufacture these cheeses are safe to eat.
Why Can Mold Grow in the Refrigerator?
While most molds prefer warmer temperatures, they can grow at refrigerator temperatures, too. Molds also tolerate salt and sugar better than most other food invaders. Therefore, molds can grow in refrigerated jams and jelly and on cured, salty meats — ham, bacon, salami, and bologna.
How Can You Minimize Mold Growth?
Cleanliness is vital in controlling mold. Mold spores from affected food can build up in your refrigerator, dishcloths, and other cleaning utensils.
Clean the inside of the refrigerator every few months with 1 tablespoon of baking soda dissolved in a quart of water. Rinse with clear water and dry. Scrub visible mold (usually black) on rubber casings using 3 teaspoons of bleach in a quart of water.
Keep dishcloths, towels, sponges, and mops clean and fresh. A musty smell means they're spreading mold around. Discard items you can't clean or launder.
Keep the humidity level in the house below 40%.
Don't Buy Moldy Foods
Examine food well before you buy it. Check food in glass jars, look at the stem areas on fresh produce, and avoid bruised produce. Notify the store manager about mold on foods!
Fresh meat and poultry are usually mold free, but cured and cooked meats may not be. Examine them carefully. Exceptions: Some salamis — San Francisco, Italian, and Eastern European types — have a characteristic thin, white mold coating which is safe to consume; however, they shouldn't show any other mold. Dry-cured country hams normally have surface mold that must be scrubbed off before cooking.
Must Homemade Shelf-Stable Preserves be Water-Bath Processed?
Yes, molds can thrive in high-acid foods like jams, jellies, pickles, fruit, and tomatoes. But these microscopic fungi are easily destroyed by heat processing high-acid foods at a temperature of 212 °F in a boiling water canner for the recommended length of time. For more information about processing home-canned foods, go to the National Center for Home Food Preservation at: www.uga.edu/nchfp/.
How Can You Protect Food from Mold?
When serving food, keep it covered to prevent exposure to mold spores in the air. Use plastic wrap to cover foods you want to stay moist — fresh or cut fruits and vegetables, and green and mixed salads.
Empty opened cans of perishable foods into clean storage containers and refrigerate them promptly.
Don't leave any perishables out of the refrigerator more than 2 hours.
Use leftovers within 3 to 4 days so mold doesn't have a chance to grow.
How Should You Handle Food with Mold on It?
Buying small amounts and using food quickly can help prevent mold growth. But when you see moldy food:
Don't sniff the moldy item. This can cause respiratory trouble.
If food is covered with mold, discard it. Put it into a small paper bag or wrap it in plastic and dispose in a covered trash can that children and animals can't get into.
Clean the refrigerator or pantry at the spot where the food was stored.
Check nearby items the moldy food might have touched. Mold spreads quickly in fruits and vegetables.
See the attached chart "Moldy Food: When to Use, When to Discard."
FOOD
HANDLING
REASON
Luncheon meats, bacon, or hot dogs
Discard
Foods with high moisture content can be contaminated below the surface. Moldy foods may also have bacteria growing along with the mold.
Hard salami and dry-cured country hams
Use. Scrub mold off surface.
It is normal for these shelf-stable products to have surface mold.
Cooked leftover meat and poultry
Discard
Foods with high moisture content can be contaminated below the surface. Moldy foods may also have bacteria growing along with the mold.
Cooked casseroles
Discard
Foods with high moisture content can be contaminated below the surface. Moldy foods may also have bacteria growing along with the mold.
Cooked grain and pasta
Discard
Foods with high moisture content can be contaminated below the surface. Moldy foods may also have bacteria growing along with the mold.
Hard cheese(not cheese where mold is part of the processing)
Use. Cut off at least 1 inch around and below the mold spot (keep the knife out of the mold itself so it will not cross-contaminate other parts of the cheese). After trimming off the mold, re-cover the cheese in fresh wrap.
Mold generally cannot penetrate deep into the product.
Cheese made with mold(such as Roquefort, blue, Gorgonzola, Stilton, Brie, Camembert)
Discard soft cheeses such as Brie and Camembert if they contain molds that are not a part of the manufacturing process. If surface mold is on hard cheeses such as Gorgonzola and Stilton, cut off mold at least 1 inch around and below the mold spot and handle like hard cheese (above).
Molds that are not a part of the manufacturing process can be dangerous.
Soft cheese(such as cottage, cream cheese, Neufchatel, chevre, Bel Paese, etc.) Crumbled, shredded, and sliced cheeses (all types)
Discard
Foods with high moisture content can be contaminated below the surface. Shredded, sliced, or crumbled cheese can be contaminated by the cutting instrument. Moldy soft cheese can also have bacteria growing along with the mold.
Yogurt and sour cream
Discard
Foods with high moisture content can be contaminated below the surface. Moldy foods may also have bacteria growing along with the mold.
Jams and jellies
Discard
The mold could be producing a mycotoxin. Microbiologists recommend against scooping out the mold and using the remaining condiment.
Fruits and vegetables, FIRM
(such as cabbage, bell peppers, carrots, etc.)
Use. Cut off at least 1 inch around and below the mold spot (keep the knife out of the mold itself so it will not cross-contaminate other parts of the produce).
Small mold spots can be cut off FIRM fruits and vegetables with low moisture content. It's difficult for mold to penetrate dense foods.
Fruits and vegetables, SOFT
(such as cucumbers, peaches, tomatoes, etc.)
Discard
SOFT fruits and vegetables with high moisture content can be contaminated below the surface.
Bread and baked goods
Discard
Porous foods can be contaminated below the surface.
Peanut butter, legumes and nuts
Discard
Foods processed without preservatives are at high risk for mold.
The U.S. Food and Drug Administration (FDA)
will detain shipments of pomegranate seeds2 from Goknur Gida Maddeleri Ithalat
Ihracat Tic (Goknur Foodstuffs Import Export Trading) of Turkey when they are
offered for import into the United States.
This action results from the investigation by the FDA, the Centers for
Disease Control and Prevention, and state and local health authorities into a
multi-state outbreak of Hepatitis A illnesses associated with Townsend Farms
Organic Antioxidant Blend, a frozen food blend containing pomegranate seed
mix.
By combining information gained from the FDA’s traceback and traceforward
investigations and the CDC’s epidemiological investigation, the FDA and CDC have
determined that the most likely vehicle for the Hepatitis A virus appears to be
a common shipment of pomegranate seeds from Goknur used by Townsend Farms to
make the Townsend Farms and Harris Teeter Organic Antioxidant Blends that were
recalled in June. These seeds were also used by Scenic Fruit Company to make
their recently recalled Woodstock Frozen Organic Pomegranate Kernels.
“This outbreak highlights the food safety challenge posed by today’s global
food system,” said Michael R. Taylor, Deputy Commissioner for Foods and
Veterinary Medicine. “The presence in a single product of multiple ingredients
from multiple countries compounds the difficulty of finding the cause of an
illness outbreak. The Hepatitis A outbreak shows how we have improved our
ability to investigate and respond to outbreaks, but also why we are working to
build a food safety system that more effectively prevents them.”
The FDA reviewed records and determined that the pomegranate seeds from this
shipment were the only ingredient common to all of the recalled Townsend Farms
and Harris Teeter Organic Antioxidant Blend.
FDA will be working with
the firms that have distributed pomegranate seeds from this shipment from Turkey
to help ensure that all recipients of these seeds are notified.
The CDC reports that as of June 27, 2013, 127 people have been confirmed to
have become ill with Hepatitis A after eating Townsend Farms Organic Antioxidant
Blend. The illnesses have been reported from 8 states: Arizona, California,
Colorado, Hawaii, Nevada, New Mexico, Utah, and Wisconsin. The people who were
reported ill in Wisconsin were exposed to the product in California.
The CDC reports that the outbreak strain of hepatitis A virus, belonging to
genotype 1B, was found in clinical specimens of 56 people in seven states: AZ
(6), CA (15), CO (22), HI (4), NM (4), NV (4) and WI (1; the person was exposed
in California). This subtype is rarely seen in the Americas but circulates in
North Africa and the Middle East.
The U.S. Food and Drug Administration and the Centers for Disease Control
and Prevention (CDC) and state and local officials are investigating a
multi-state outbreak of Hepatitis A illnesses potentially associated with a
frozen food blend. We are moving quickly to learn as much as possible and
prevent additional people from becoming ill. We recognize that people will be
concerned about this outbreak, and we will continue to provide updates and
advice.
What is the Problem and What is Being Done About
It?
The FDA, the CDC, and state and local
officials are investigating a multi-state outbreak of Hepatitis A illnesses
potentially associated with Townsend Farms Organic Antioxidant Blend, a frozen
blend containing pomegranate seed mix.
As of June 27, 2013, 127 people infected with Hepatitis A have been reported
from 8 states: Arizona, California, Colorado, Hawaii, Nevada, New Mexico, Utah,
and Wisconsin. The cases from Wisconsin were exposed to the product in
California.
The CDC reports that the outbreak strain of Hepatitis A virus (HAV),
belonging to genotype 1B, was found in clinical specimens of 56 people in 7
states. This strain is rarely seen in the Americas but circulates in North
Africa and the Middle East.
The product was sold at Costco warehouse stores
under the product name Townsend Farms Organic Antioxidant Blend4, 3 lb. bag and UPC 0 78414 404448. The
recalled codes are located on the back of the package with the words “BEST BY”;
followed by the code T012415 sequentially through T053115, followed by a letter.
All of these letter designations are included in this recall for the lot codes
listed above.
The product was also sold at Harris Teeter stores
from April 19 until May 7, 2013, under the product name Harris Teeter Organic Antioxidant
Berry Blend5, 10 oz. bag and
UPC 0 72036 70463 4, with Lot Codes of T041613E or T041613C and a “BEST BY” code
of 101614.
On
June 28, 2013, Townsend Farms, Inc. expanded its recall6 to include Townsend Farms Organic
Antioxidant Blend, 3 lb. bag with UPC number 0 78414 40444 8. The recall codes
are located on the back of the package with the words “BEST BY” followed by the
code T122114 sequentially through T053115, followed by a letter. All letter
designations are included in the recall.
On June 14, 2013, the Jackson County Oregon Health Department warned
customers of Evo’s Coffee Lounge, in Ashland, Oregon, that they may have been
exposed to Hepatitis A in the coffee shop's "Radically Free" smoothie served
between May 17 and June 12, 2013. The coffee shop used Townsend Farms Organic
Antioxidant Blend to produce this menu item. The Jackson County Health
Department also alerted those who may have been exposed in the last 14 days of
the availability of Hepatitis A vaccine in the local area.
On June 19, 2013, the Mendocino County Public Health Department
warned customers of A Frame Espresso in Fort Bragg Calif. that they may have
been exposed to Hepatitis A in the coffee shop's "Mixed Berry" smoothie served
between March 4 and June 8, 2013. The smoothies may have contained Townsend
Farms Organic Antioxidant Blend.
Woodstock
Organic Pomegranate Kernels are sold in eight-ounce (227 gram) resealable
plastic pouches (see
image8) with UPC Code 0 42563
01628 9. Specific coding information to identify the product can be found on the
back portion of these pouches below the zip-lock seal. The following lots are
subject to this recall:
C 0129 (A,B, or C) 035 with a best by date of
02/04/2015
C 0388 (A,B, or C) 087 with a best by date of 03/28/2015
C 0490 (A,B, or C) 109 with a best by date of 04/19/2015
The recalled Scenic Fruit products were shipped from February 2013 through
May 2013 to United Natural Foods, Inc. (UNFI) distribution centers in
California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New
Hampshire, Pennsylvania, Rhode Island, Texas, and Washington State. UNFI
distribution centers may have further distributed products to retail stores in
other states.
The FDA has finalized a protocol to test berries for the Hepatitis A virus
(HAV), and is testing samples related to the outbreak for the presence of
HAV.
The FDA has also inspected the processing facilities of Townsend Farms of
Fairview, Oregon. By combining information gained from the FDA’s traceback and
traceforward investigations and the CDC’s epidemiological investigation, the FDA
and CDC have determined that the most likely vehicle for the Hepatitis A virus
appears to be a common shipment of pomegranate seeds from Goknur used by
Townsend Farms to make the Townsend Farms and Harris Teeter Organic Antioxidant
Blends that were recalled in June. These seeds were also used by Scenic Fruit
Company to make their recently recalled Woodstock Frozen Organic Pomegranate
Kernels.
The FDA reviewed records and determined that the pomegranate seeds from this
shipment were the only ingredient common to all of the recalled Townsend Farms
and Harris Teeter Organic Antioxidant Blend.
FDA will be working with
the firms who have distributed pomegranate seeds from this shipment from Turkey
to help ensure that all recipients of these seeds are notified.
The FDA is working closely with the CDC and state and local agencies and will
provide updates as soon as they become
available.
What is Hepatitis A?
Hepatitis A is a contagious
liver disease that results from infection with the Hepatitis A virus. It can
range in severity from a mild illness lasting a few weeks to a severe illness
lasting several months. Hepatitis A is usually spread when a person ingests
fecal matter — even in microscopic amounts — from contact with objects, food, or
drinks contaminated by the feces, or stool, of an infected person.
What are the Symptoms of Hepatitis A?
Illness
occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain,
jaundice, abnormal liver tests, dark urine and pale stool.
Who is at Risk?
Hepatitis A is a human disease and
usually occurs when an infected food handler prepares food without appropriate
hand hygiene. However, food contaminated with HAV, as is suspected in this
outbreak, can cause outbreaks of disease among persons who eat or handle
food.
In rare cases, particularly in patients with pre-existing severe illness or
immune compromise, HAV infection can progress to liver failure and death.
Persons with underlying liver conditions should be vaccinated.
What is being Recalled?
On June
4, 2013, Townsend Farms, Inc.
of Fairview, Oregon, recalled certain lots of its frozen Organic Antioxidant
Blend9 on June 4, 2013,
because it has the potential to be contaminated with Hepatitis A virus. No
other Townsend Farms products, frozen or fresh, are covered by this voluntary
recall or linked to the illness outbreak at this time. The product was sold at
Costco warehouse stores under the product name Townsend Farms Organic
Antioxidant Blend10, 3 lb. bag
and UPC 0 78414 404448. The recalled codes are located on the back of the
package with the words “BEST BY”; followed by the code T012415 sequentially
through T053115, followed by a letter. All of these letter designations are
included in this recall for the lot codes listed above.The product was also sold
at Harris Teeter stores from April 19 until May 7, 2013, under the product name
Harris Teeter Organic
Antioxidant Berry Blend11, 10
oz. bag and UPC 0 72036 70463 4, with Lot Codes of T041613E or T041613C and a
“BEST BY” code of 101614.
On
June 28, 2013, Townsend Farms, Inc. expanded its recall12 to include Townsend Farms Organic
Antioxidant Blend, 3 lb. bag with UPC number 0 78414 40444 8. The recall codes
are located on the back of the package with the words “BEST BY” followed by the
code T122114 sequentially through T053115, followed by a letter. All letter
designations are included in the recall.
Woodstock
Organic Pomegranate Kernels are sold in eight-ounce (227 gram) resealable
plastic pouches (see
image14) with UPC Code 0 42563
01628 9. Specific coding information to identify the product can be found on the
back portion of these pouches below the zip-lock seal. The following lots are
subject to this recall:
C 0129 (A,B, or C) 035 with a best by date of
02/04/2015
C 0388 (A,B, or C) 087 with a best by date of 03/28/2015
C 0490 (A,B, or C) 109 with a best by date of 04/19/2015
The recalled Scenic Fruit products were shipped from February 2013 through
May 2013 to United Natural Foods, Inc. (UNFI) distribution centers in
California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New
Hampshire, Pennsylvania, Rhode Island, Texas, and Washington State. UNFI
distribution centers may have further distributed products to retail stores in
other states.
Woodstock
Organic Pomegranate Kernels are sold in eight-ounce (227 gram) resealable
plastic pouches (see
image16) with UPC Code 0 42563
01628 9. Specific coding information to identify the product can be found on the
back portion of these pouches below the zip-lock seal. The following lots are
subject to this recall:
C 0129 (A,B, or C) 035 with a best by date of
02/04/2015
C 0388 (A,B, or C) 087 with a best by date of 03/28/2015
C 0490 (A,B, or C) 109 with a best by date of 04/19/2015
The recalled Scenic Fruit products were shipped from February 2013 through
May 2013 to United Natural Foods, Inc. (UNFI) distribution centers in
California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New
Hampshire, Pennsylvania, Rhode Island, Texas, and Washington State. UNFI
distribution centers may have further distributed products to retail stores in
other states.
What Do Consumers and Retailers Need To Do?
Consumers
should not eat the recalled products and should discard any remaining product
from their freezers. Even if some of the product has been eaten without anyone
in your home becoming ill, the rest of the product should be discarded.
Retailers and other food service operators should not sell or serve the
recalled products.
See the CDC's recommendations concerning vaccination
for Hepatitis A in regard to this outbreak here17.
Who Should be Contacted?
For more information on
the Townsend Farms recall, consumers may contact a Townsend Farms Customer
Service Representative by phone or e-mail at 1-800-875-5291; townsendfarms5148@stericycle.com.
Customer service representatives will be available Monday through Friday, 7 a.m.
to 4 p.m. PDT to respond to inquiries.
For more information on the Scenic Fruit Company
recall, consumers may contact the Scenic Fruit Company at 877-927-3434 or email
to info@scenicfruit.com from Monday through Friday, 8
a.m. to 8 p.m. PDT
For information on Hepatitis A and the vaccine, consumers may call the CDC
information line at 1-800-CDC INFO between 8 a.m. and 8 p.m. Eastern time.
The FDA encourages consumers with questions about
food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4
p.m. Eastern time, or to consult the fda.gov website: www.fda.gov18.
The information in this release reflects the FDA’s best efforts to
communicate what it has learned from the manufacturer and the state and local
public health agencies involved in the investigation. The agency will update
this page as more information becomes available. For more information:
Foodborne Illness: Especially Dangerous for the Vulnerable
If you've ever become sick after eating a food contaminated with
disease-causing bacteria, it's not an experience you want to repeat.
But if you're part of what is called an "at-risk" or "vulnerable" population,
a foodborne illness can be extremely dangerous. Symptoms—such as vomiting,
diarrhea and fever—can intensify and the illness can become
life-threatening.
Which populations are most at risk?
According to Food and Drug Administration
(FDA) epidemiologist Karl Klontz, M.D., M.P.H., they are the very young (under 1
year); older adults; the immune-compromised (those whose immune systems are less
able to fight off harmful bacteria); and women who are pregnant.
For a particular type of bacteria known as
Listeria monocytogenes—which causes a serious illness called
listeriosis—the list is much the same, according to Vital
Signs5, a new report from
the Centers for Disease Control and Prevention (CDC). The report, which
summarizes data on the 1,651 listeriosis cases reported from 2009-2011, shows
that older adults, pregnant women, newborns and persons with conditions that
hinder the immune system are at a higher risk than others for listeriosis.
Combined, these vulnerable groups accounted for at least 90 percent of the
listeriosis cases. CDC reported that 21 percent of the people with listeriosis
died.
The following groups are at increased risk:
Pregnant women: Pregnant women are about 10 times more likely than the general population to get listeriosis. About one in seven (14%) cases of listeriosis occurs during pregnancy.
Newborn babies: Newborn babies suffer the most serious effects of infection in pregnancy.
Persons with weakened immune systems from transplants or certain diseases, therapies, or medications.
Persons with cancer, diabetes, alcoholism, liver or kidney disease.
Persons with AIDS: They are almost 300 times more likely to get listeriosis than people with normal immune systems.
Older adults
Healthy children and adults occasionally get infected with Listeria, but they rarely become seriously ill.
Immune System Plays a Role
What makes these populations more at risk? In many cases, the problem lies
with the immune system, says Klontz. The immune system is the body's natural
defense system against "foreign invasion" by pathogens (bacteria or viruses that
can cause disease). In healthy people, a properly functioning immune system
usually fights off harmful pathogens readily.
As we age, our immune functions and other barriers to infection start to
wane, says Klontz. Our bodies less effectively fight off harmful bacteria. For
example, the amount of acid in our stomachs, once a powerful barrier to
pathogens, decreases. In addition, older people tend to take more medications
for problems like heartburn or acid reflux, many of which further reduce the
amount of stomach acid, further reducing this barrier against pathogens.
The same goes for people with compromised immune systems, such as those with
HIV/AIDS, cancer, liver disease and diabetes. "Not only are their immune systems
weakened by the disease," Klontz says, "but the side effects from certain
treatments such as chemotherapy may make them weaker still."
On the opposite side of the age spectrum are children. Young children, in
particular, are more at risk for foodborne illness because their immune systems
are still developing.
As for pregnant women, "I wouldn't say that their immune systems are
compromised so much as altered, serving a specific purpose—to enable the mother
to co-exist with the fetus throughout the nine months of pregnancy. "Remember
that half of the fetus' genes are not the mother's," Klontz says. The body has
to work extra hard to avoid rejecting it. But that same alteration makes the
body more susceptible to infection, he notes.
In addition, listeriosis in pregnant women can cause miscarriage, still
birth, premature labor, and serious illness or death in newborns. Listeria
monocytogenes, in particular, can cross the placenta (an organ which links
the blood supply of mother to child) and infect the unborn baby.
Prevention is Key
Key to reducing the risk faced by these vulnerable populations is to prevent
foodborne illnesses from occurring in the first place, says FDA microbiologist
Mickey Parish, Ph.D. Prevention is at the heart of the FDA Food Safety
Modernization Act (FSMA) signed into law in 2011.
FDA is working toward putting new measures in place to help keep contaminants
out of the harvesting, processing and manufacturing of foods, Parish notes. By
establishing safety and cleanliness requirements for farmers, food companies,
and importers, FDA expects that implementation of FSMA will reduce the chances
that pathogens such as Listeria, Salmonella, and
E.coli will reach those most at risk.
There are steps that the people particularly vulnerable to the dangers of
foodborne illnesses can take to reduce that risk, says Klontz. These
include:
Avoid eating raw animal products, which include unpasteurized milk (and
cheeses made from unpasteurized milk), uncooked or lightly cooked eggs, and raw
fish and meat dishes such as sushi or steak tartare.
Wash fruits and vegetables before eating, especially foods with rinds, such
as cantaloupes and other melons. Avoid eating raw sprouts.
Make sure counters and other food preparation surfaces are adequately
cleaned.
Avoid hot dogs and other deli-style meats unless they are reheated to
steaming temperatures. Also avoid deli-prepared salads, such as chicken or
seafood salad.
Keep your refrigerator at 40 degrees F or lower, and your freezer at 0
degrees F or lower.
If you're eating out, notes Klontz, especially if you're in an at-risk group,
it's helpful to ask what ingredients are in a prepared dish. Are any raw or
uncooked? Is the salad dressing or sauce made with unpasteurized milk or eggs?
Does it include any raw animal products?
This article appears on FDA's Consumer Updates
page6, which features the
latest on all FDA-regulated products.
CDC: Infections from two foodborne germs increased during 2012
CDC. MMWR. 2013;62;283-287.
April 18, 2013
The incidence of infections caused by Campylobacter and Vibrio increased in 2012 by 14% and 43%, respectively, compared with rates from 2006 to 2008, according to findings published in Morbidity and Mortality Weekly Report. The Foodborne Diseases Active Surveillance Network (FoodNet) conducted surveillance in 10 US sites (15% of the population) for laboratory-confirmed infections. FoodNet reported 19,531 illnesses, 4,563 hospitalizations and 68 deaths from nine infections that are transmitted commonly through food.
“Following the trends over time ... offers some insights to many partners on how to save lives and protect people,” Robert Tauxe, MD, MPH, deputy director of the CDC Division of Foodborne, Waterborne and Environmental Diseases, said during a press conference. “Every year we estimated that about 48 million people, or one in six people, in the US get sick from eating contaminated food.”
Researchers found the number of infections and incidence per 100,000 population, by pathogen, were Salmonella (7,800; 16.42), Campylobacter (6,793; 14.3), Shigella (2,138; 4.5), Cryptosporidium (1,243; 2.6), Shiga toxin-producing Escherichia coli (STEC) non-O157 (551; 1.16), STEC O157 (531; 1.12), Vibrio (193; 0.41), Yersinia (155; 0.33), Listeria (121; 0.25) and Cyclospora (15; 0.03).
“Once again, Salmonella was the most commonly diagnosed and reported cause of infection among those that are tracked,” Tauxe said. “The frequency of Salmonella, in general, in the population that FoodNet follows has remained constant over time since 1996.”
Compared with the 1996 to 1998 period, infections associated with Campylobacter, Listeria, Shigella, STEC O157 and Yersinia were significantly lower in 2012, but Vibrio infections were significantly higher.
According to researchers, adults aged 65 years or older were hospitalized most frequently; 67% for STEC O157, 58% for Vibrio, 55% for Salmonella, 50% for Cyclospora, 41% for Shigella, 34% for STEC non-O157, 33% for Cryptosporidium and 31% for Campylobacter. Deaths also were highest among those aged 65 years or older.
“FDA is concerned that the rates of these major foodborne illnesses have not decreased in recent years, and certainly these data from CDC highlight the importance of new rules from the Food Safety Modernization Act, which will help reduce foodborne illness,” Jeff Farrar, DVM, MPH, PhD, director of Intergovernmental Affairs and Partnerships at the FDA, said during the press conference.
Disclosure: The researchers report no relevant financial disclosures.
The CDC released a study today on foodborne illnesses via CDC’s Foodborne Disease Outbreak Surveillance System which reported; During 2009–2010, beef, dairy, fish, and poultry were associated with the largest number of foodborne disease outbreaks.
What is added by this report?
Among the 1,527 foodborne disease outbreaks reported in 2009 and 2010, most outbreak-associated illnesses were caused by norovirus or Salmonella. Among outbreaks in which both an etiologic agent and single-commodity food vehicle were identified, most outbreaks were attributed to Campylobacter in unpasteurized dairy products, Salmonella in eggs, and Shiga toxin–producing Escherichiacoli O157 in beef. The pathogen-commodity pairs responsible for the most outbreak-related illnesses were Salmonella in eggs (2,231 illnesses), in sprouts (493), and in vine-stalk vegetables (422).
View the report;
This Week in MMWR January 25, 2013 / Vol. 62 / No. 3
Known pathogens cause an estimated 9.4 million foodborne illnesses annually in the United States. During 2009–2010, a total of 1,527 foodborne disease outbreaks (675 in 2009 and 852 in 2010) were reported in the United States via CDC’s Foodborne Disease Outbreak Surveillance System. This report summarizes findings from that surveillance....
NEW YORK (AP) -- A big government study has fingered leafy greens like lettuce and spinach as the leading source of food poisoning, a perhaps uncomfortable conclusion for health officials who want us to eat our vegetables.
Each year roughly 1 in 6 Americans - or 48 million people- gets sick from food poisoning. That includes 128,000 hospitalization and 3,000 deaths, according to previous CDC estimates.
The new report is the most comprehensive CDC has produced on the sources of food poisoning, covering the years 1998 through 2008. It reflects the agency's growing sophistication at monitoring illnesses and finding their source
Leafy greens such as lettuce, spinach and kale accounted for the most food-borne illnesses nationwide from 1998 through 2008, the Centers for Disease Control and Prevention reports.
Dairy products accounted for the most hospitalizations. The most deaths were linked to poultry.
The study isn't meant to be a "risk of illness per serving" list for consumers, said Patricia Griffin, a food-borne disease expert at the CDC who was the senior author of the report. The statistics are meant to help regulators and the food industry target efforts to improve the safety of food.
"The vast majority of meals are safe," she said, so don't let the numbers for leafy greens keep you from eating vegetables. "Eating them is so important to a healthy diet. They're linked to reduced risk of heart attacks, stroke and cancer."
The study looked at 4,887 outbreaks that caused 128,269 illnesses, hospitalizations and deaths when the food that caused them was known or suspected. It appears Tuesday in the journal Emerging Infectious Diseases.
Epidemiologists at the CDC found that leafy greens accounted for 23% of illnesses and dairy products 14%. However, when they looked only at hospitalizations, the lineup was different: Dairy products were responsible for 16% of hospitalizations followed by leafy vegetables at 14% and poultry 12%. For deaths, poultry accounted for 19%, then dairy products at 10%.
The overall number of deaths was small: 277 people died from food-borne illnesses linked to poultry and 140 from illnesses linked to dairy products during those years.
While the statistical details won't be all that helpful to consumers, it's "essential" for government agencies and the food industry as they work to make food safer, Griffin said.
That's especially the case now that implementation of the Food Safety Modernization Act is underway. The act requires the Food and Drug Administration to focus its regulatory efforts on the highest-risk food products. Until now, they were hard to identify.
Griffin cautions that the dairy product numbers are misleading. Many of the outbreaks linked to dairy products involve unpasteurized milk and cream, but the vast majority of Americans drink and eat only pasteurized dairy products.
"The weight of the raw milk outbreaks is making it look as if dairy is a bigger source of illness than we actually think it is," she said.
A study published last year that looked at 13 years of outbreaks linked to dairy products found that unpasteurized milk, cheese and cream were 150 times more likely to cause food-borne illness outbreaks than pasteurized dairy foods and that such outbreaks had a hospitalization rate 13 times higher than those involving pasteurized dairy products.
FDA warns consumers not to eat shellfish from Oyster Bay Harbor, Nassau County, NY
The U.S. Food and Drug Administration is warning consumers not to eat raw or
partially cooked oysters and clams (shellfish) with tags listing Oyster Bay
Harbor, in Nassau County, N.Y., as the harvest area, following illnesses
reported in several states caused by Vibrio parahaemolyticus bacteria.
Shellfish harvested from Oyster Bay Harbor have been linked to confirmed and
possible cases of Vibrio parahaemolyticus illness.
Ill persons reported consumption of raw or partially cooked shellfish from
the affected area.
The New York state Department of Environmental Conservation (DEC) closed
Oyster Bay Harbor, on July 13 to shellfish harvesting.
All shellfish harvesters, shippers, re-shippers, processors, restaurants,
and retail food establishments are advised to check the identity tags on all
containers of shellfish in their inventories. If the tag indicates the harvest
area was Oyster Bay Harbor and a harvest date on or after June 1, 2012, the
product should be disposed of and not be sold or served.
What are the Symptoms of Vibrio parahaemolyticusIllness?
Illness is typically characterized by nausea, vomiting, and diarrhea. The
symptoms begin from a few hours to as many as five days after consumption of raw
or undercooked seafood, particularly shellfish.
What do Consumers Need to Do?
Consumers possessing shellfish with tags listing Oyster Bay Harbor as the
harvest area and a harvest date on or after June 1, 2012 should dispose of and
not eat the shellfish. Consumers possessing shellfish for which the harvest area
is not known should inquire of the retailer, restaurant or other facility about
the source of shellfish. If the shellfish was already consumed and no one became
ill, no action is needed. However, if you develop a diarrheal illness within a
week after consuming raw or undercooked shellfish, see your health care provider
and inform the provider about this exposure.
Where was the Shellfish Distributed?
Records and information obtained by the New York state DEC indicate that
the shellfish from this area of Oyster Bay Harbor in New York were distributed
in several states, including, but not necessarily limited to, Connecticut,
Maine, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York,
Pennsylvania and Rhode Island.
What is Being Done About the Problem?
The New York state DEC has prohibited the harvesting of shellfish from
Oyster Bay Harbor in Nassau County, and has issued media releases advising
establishments not to use shellfish from this harvest area and advising
consumers not to eat the shellfish. The DEC has notified states that received
implicated shellfish and the Interstate Shellfish Sanitation Conference, which
has subsequently notified its membership.
The map at http://www.dec.ny.gov/outdoor/7765.html1 shows the area that has been closed to
harvesting of shellfish. This closure will remain in effect until samples
collected by the DEC indicate that shellfish from the affected area are no
longer a threat to consumers.
No other harvest areas have been implicated in the recent Vibrio
parahaemolyticus illnesses.
Who Should be Contacted?
Consumers with questions about seafood safety may
call the FDA at 1-888-SAFEFOOD or email consumer@fda.gov.
The information in this press release reflects the FDA’s best efforts to
communicate what it has learned from state and local public health agencies
involved in the investigation. The agency will provide updates as more
information becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
There are three things this blogger is obsessed with - bed bugs, parasites and foodborne illness.
Today on the blog we have two resources with information on Vibrio vulnificus, an organism found in raw or poorly cooked seafood- (raw oysters,sushi).
A Warning For People With Liver Cirrhosis
According to data found at Medscape; "Among all foodborne diseases, V vulnificus infection is associated with the highest case fatality rate (39%).
Patients with cirrhosis who consumed raw oysters were 80 times more likely to develop V vulnificus infection and 200 times more likely to die of the infection than those without liver disease who consumed raw oysters"
In the first article from "text book of bacteriology" interesting details on Vibrio vulnificus, V. cholerae and V. parahaemolyticus are discussed.
You might remember the latter in the headlines last year when the FDA announced a recall on oysters affecting 23 states. The agency issued a warning to consumers not to eat raw oysters harvested from an area of Hood Canal in Washington State following an outbreak of illness caused by Vibrio parahaemolyticus bacteria - scary stuff.
In the second article published @ "ACP internist.org," Thomas A. Moore, MD, offers this warning;
"There are many reasons not to eat them. Hepatitis A is one; another is toxoplasmosis. The biggest risk factor for acquiring this parasitic infection is the consumption of raw oysters," Dr. Moore said. "It's like Russian roulette. Eating [raw oysters] is OK now and then, but if you go on a bender, you're gonna get it," he said.
Certain health conditions put people at high risk for serious illness or death from V. vulnificus infections. These conditions include:
Liver disease (from hepatitis, cirrhosis, alcoholism, or cancer) Iron overload disease (hemochromatosis)
Diabetes
Cancer (including lymphomas, leukemia, Hodgkin's disease)
Stomach disorders-a high use of antacids
Any illness or medical treatment that weakens the body's immune system, including HIV infection
You can get sick from Vibrio vulnificus in two ways:
Eating raw or undercooked shellfish
You can also get infected by getting seawater on an open wound, cut, sore or puncture. The bacterium can enter through the break in the skin and cause infection. In some people the infection heals by itself, while in others it progresses to severe infection of the skin and underlying tissues.
Vibrio vulnificus (This article has 3 chapters)
Kenneth Todar, PhD
Vibrio vulnificus is scarcely recognized by many microbiologists, less so by the public. Yet, in this country, the bacterium causes a disease with over a 50 percent mortality rate, and it causes 95 percent of all seafood-related deaths.
Vibrio vulnificus is a Gram-negative, motile curved bacterium found in marine and estuarine environments. It has been isolated from seawater, sediments, plankton and shellfish (oysters, clams and crabs) located in the Gulf of Mexico, the Atlantic Coast as far north as Cape Cod, and the entire U.S. West Coast. The bacterium thrives in warm seawater and is part of a group of vibrios that are "moderate halophiles", meaning they require salt for growth. Vibrios are frequently isolated from oysters and other shellfish in warm coastal waters during the summer months. This correlates with the peak incidence of disease caused by the bacterium.
Vibrio vulnificus is a Gamma Proteobacterium in the Family Vibrionaceae, with two other human pathogens Vibrio cholerae, the agent of epidemic cholera, and Vibrio parahaemolyticus, which causes acute diarrhea. Vibrios are one of the most common organisms in surface waters of the world. They occur in both marine and freshwater habitats and in associations with aquatic animals. Some species are bioluminescent and live in mutualistic associations with fish and other marine life. Other species are pathogenic for fish, eels, and frogs, as well as other vertebrates and invertebrates.
V. cholerae and V. parahaemolyticus are pathogens of humans. Both produce diarrhea, but in ways that are entirely different. V. parahaemolyticus is an invasive organism affecting primarily the colon; V. cholerae is noninvasive, affecting the small intestine through secretion of an enterotoxin.
Vibrio vulnificus is an emerging pathogen of humans. It causes wound infections, gastroenteritis, or a syndrome known as primary septicemia. It was first recognized as an agent of disease in 1976. The first documented case of disease caused by the bacterium was in 1979.
Figure 1. Vibrio vulnificus is a typical marine vibrio - a slightly curved bacterium, motile by means of a single polar flagellum.
Disease
V. vulnificus causes disease in individuals who eat contaminated seafood (usually raw or undercooked oysters) or have an open wound that is exposed to seawater. Among healthy people, ingestion of V. vulnificus can cause vomiting, diarrhea, and abdominal pain. Most V. vulnificus infections are acute and have no long-term consequences.
In immunocompromised persons, particularly those with chronic liver disease, V. vulnificus can invade the bloodstream from either a wound or from the GI tract, causing a severe and life-threatening illness called primary septicemia, characterized by fever, chills, septic shock and death. Blistering skin lesions accompany the disease in about 70% of the cases. V. vulnificus bloodstream infections are fatal about 50% of the time.
Although V. vulnificus is a rare cause of disease, it is likely that it is unrecognized and underreported (one estimate of the total number of cases annually in the U.S. is as high as 45,000). Between 1988 and 1995, CDC received reports of over 300 V. vulnificus infections from the Gulf Coast states, where the majority of cases occur.
United States Between 1998 and 2010, the incidence of Vibrio infections increased by more than 115%. The CDC estimates that 80,000 Vibrio infections (200 V vulnificus, 45,000 V parahaemolyticus, and 35,000 Vibrio species.) and approximately 100 deaths related to Vibrio infections may occur annually in the United States.[2] Vibrio infections are acquired through consumption of contaminated raw or undercooked shellfish such as oysters, clams, mussels, or crabs. Exposure of wounds to contaminated seawater, injury caused by contaminated seashells, and shark and alligator bites are potential alternative sources of infection.
V parahaemolyticus is the leading cause of seafood-associated gastroenteritis in the United States. During a large outbreak of gastroenteritis in July 2004 in the Gulf of Alaska, V parahaemolyticus caused illness in almost one third of cruise ship passengers who consumed Vibrio -contaminated oysters. From May to July 2006, health departments of New York City, New York state, Oregon, and Washington state reported a total of 177 cases of V parahaemolyticus gastroenteritis. Of these reported cases, 113 (64%) involved residents of Washington state
We continue with the article from "text book of bacteriology"
Persons who are immunocompromised, especially those with chronic liver disease, are at risk for V. vulnificus when they eat raw seafood, particularly oysters. These individuals are 80-200 times more likely to develop V. vulnificus primary septicemia than are healthy people. For this particular risk group, the infection carries one of the highest mortality rates of all bacterial infections.
Health conditions that place a person at risk for serious illness or death from V. vulnificus infection include liver disease, hemochromatosis, diabetes, stomach problems, kidney disease, cancer, immune disorders (including HIV) and long-term steroid use. In these individuals, the bacterium enters the blood stream, resulting in septic shock, rapidly followed by death in many cases. Such individuals are strongly advised not to consume raw or inadequately cooked seafood.
There is substantial evidence that Vibrio-associated diseases are increasing worldwide with climate warming
Long-term effects of ocean warming on the prokaryotic community: evidence from the vibrios
The long-term effects of ocean warming on prokaryotic communities are unknown because of lack of historical data. We overcame this gap by applying a retrospective molecular analysis to the bacterial community on formalin-fixed samples from the historical Continuous Plankton Recorder archive, which is one of the longest and most geographically extensive collections of marine biological samples in the world. We showed that during the last half century, ubiquitous marine bacteria of the Vibrio genus, including Vibrio cholerae, increased in dominance within the plankton-associated bacterial community of the North Sea, where an unprecedented increase in bathing infections related to these bacteria was recently reported. Among environmental variables, increased sea surface temperature explained 45% of the variance in Vibrio data, supporting the view that ocean warming is favouring the spread of vibrios and may be the cause of the globally increasing trend in their associated diseases. Continue Reading...
Scientific Meeting News for April 19, 2012
Like gambling? Eat raw oysters
If you're considering sampling local seafood while in town, you might want to steer clear of raw oysters, said Thomas A. Moore, MD, FACP, chair of infectious diseases at Oschner Medical Center in New Orleans, at a talk during Wednesday's Hospital Medicine precourse.
"There are many reasons not to eat them. Hepatitis A is one; another is toxoplasmosis. The biggest risk factor for acquiring this parasitic infection is the consumption of raw oysters," Dr. Moore said. "It's like Russian roulette. Eating [raw oysters] is OK now and then, but if you go on a bender, you're gonna get it," he said.
Another risk—and the subject of a portion of his talk—is Vibrio vulnificus. The organism is part of the normal marine flora, especially oysters, and tends to cause disease in warmer months. With a mortality rate of 50%, it accounts for 90% of all seafood-related U.S. deaths. A few years ago, The Sunday Times (of London) food critic Michael Winner nearly lost his leg from contracting the illness after eating a bad oyster, Dr. Moore noted.
Cases related to V. vulnificus have been increasing along the Gulf Coast, "perhaps due to global warming," Dr. Moore said.
Refraining from eating the raw mollusks won't entirely protect you from the skin and soft tissue infection caused by the organism, though, as it can be contracted from nonfoodborne exposure too, he said. Still, 90% of patients who get ill from V. vulnificus report having eaten oysters within the previous seven days, he noted.
Typically, the illness starts with abrupt onset of rigors, then fever and prostration. This is followed by hypotension in a third of cases. In 75% of cases, metastatic skin lesions develop with 36 hours of initial symptom onset, usually on the extremities, with the legs being more common than the arms. Leukopenia and thrombocytopenia are also common, but not universal, he said.
"Vibrio vulnificus is primarily associated with severe, distinctive soft tissue infection and/or septicemia," Dr. Moore said. "What you usually don't see is diarrhea; it invades the bloodstream without causing [gastrointestinal] symptoms."
Patients typically develop sepsis within 16 hours of symptoms and cellulitis somewhere between four hours and four days (the mean time is 12 hours), he said.
Physicians should consider V. vulnificus when a patient has septicemia associated with necrotizing skin lesions; is immunocompromised, as with liver disease; and has ingested or was exposed to oysters and/or salt water in the past one to three days.
If you do suspect V. vulnificus, be sure to alert the lab that is performing tests, as it may otherwise be missed. Only 25% of labs in Gulf Coast states routinely culture for the bacteria, he said.
In treating complicated skin and soft tissue infection due to V. vulnificus, the best option is tetracycline. Other good options include ceftriaxone and ciprofloxacin.
Patients with cellulitis from V. vulnificus respond well to antibiotics, but early diagnosis is critical as the condition progresses rapidly, Dr. Moore added. Early surgical consultation is also advised. "These patients often need early and aggressive debridement," he said.
Patients who have developed bacteremia don't respond as well to treatment, though starting antibiotics within 24 hours of the onset of symptoms does help lower mortality for these folks, he said.
Those who still want to ingest raw oysters after learning the potential consequences can lower their chances of getting sick by using tabasco, noted Dr. Moore. Research suggests the vinegar in the condiment inhibits the growth of V. vulnificus, so the higher the vinegar content of your chosen brand, the better, he said.
Since the very first tar balls began rolling onshore along the Gulf of Mexico following 2010’s Deepwater Horizon oilrig explosion and subsequent underwater oil geyser, the oil industry told us to relax because those tar balls were completely harmless. But as we approach the two year anniversary of the disaster, new studies have confirmed that the tar balls we’re seeing along our beaches contain bacteria that are capable of killing human beings.
The new study, conducted by scientists at Auburn University, confirmed the presence of a bacteria called Vibrio vulnificus. According to researchers, this is the same bacteria that is responsible for causing illness and death from eating bad oysters. The tar balls contained concentrations of this bacteria more than 100 times greater than the surrounding water. The Centers for Disease Control says the following regarding Vibrio vulnificus:
Wound infections may start as redness and swelling at the site of the wound that then can progress to affect the whole body. V. vulnificus typically causes a severe and life-threatening illness characterized by fever and chills, decreased blood pressure (septic shock), and blood-tinged blistering skin lesions (hemorrhagic bullae). Overall, V. vulnificus infections are fatal about 40% of the time.Wound infections with V. vulnificus are fatal about 20% of the time, and aggressive surgical treatment can prevent death.
Persons who have immunocompromising conditions and especially persons with chronic liver disease are particularly at risk for V. vulnificus infection when they eat raw or undercooked seafood, particularly shellfish harvested from the Gulf of Mexico, or if they bathe a cut or scrape in marine waters. About three-quarters of patients with V. vulnificus infections have known underlying hepatic disease or other immunocompromising illness. Otherwise healthy persons are at much lower risk of V. vulnificus infection.
It is important to remember that this isn’t a fleeting threat to those of us who live, work, and play along the Gulf Coast. National Geographic recently pointed out that tarballs are continuously washing up along the coasts of the Gulf of Mexico, meaning that the threat of bacterial infection is not only real, but it is persistent. And with Spring Break season in high gear, beaches along the Gulf Coast are currently inundated with out of state families playing and relaxing on top of these toxic bacteria balls.
As this week comes to a close we take a look back at the most relevant HCV headlines, including today's news with updates as the day progresses. Click here to view previous or future TGIF articles.
Idenix Announces Removal of the Partial Clinical Hold on HCV Nucleotide Inhibitor, IDX184
CAMBRIDGE, Mass., Feb. 3, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the partial clinical hold on IDX184 has been removed and that the Company's 12-week phase IIb study evaluating IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV) may continue. IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection is a pan-genotypic oral nucleotide polymerase inhibitor, and has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies. Recently announced interim phase IIb data demonstrated favorable antiviral activity and no serious adverse events.
"After review of the interim safety and antiviral activity results from the IDX184 phase IIb clinical trial, the FDA removed the partial clinical hold and has allowed us to continue enrollment of this study," Ron Renaud, President and Chief Executive Officer of Idenix, commented. "Importantly, this allows us to expand the phase IIb program and evaluate IDX184 in interferon-free combination regimens with other direct-acting antivirals. We are working toward beginning all-oral combination trials as quickly as possible."
About IDX184 Phase IIb Study
In July 2011, Idenix initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Study objectives include safety and tolerability, and antiviral activity endpoints. The FDA has agreed to truncate the study from 100 patients, as in the original protocol, to a total of 60 patients, and to expand the enrollment criteria.
About IDX184 Partial Clinical Hold
A clinical hold originally was issued in September 2010 as a result of three cases of elevated liver function tests observed during a drug-drug interaction study in healthy volunteers of the combination of IDX184 and IDX320, an investigational HCV protease inhibitor. Idenix reviewed available data and conducted additional preclinical studies. With the help of independent experts and an external safety committee, the Company concluded that the observed toxicity was likely caused by IDX320 and submitted all data to the FDA. At the beginning of 2011, the FDA removed a full clinical hold on IDX184, and the program was placed on partial clinical hold allowing the Company to initiate the 12-week phase IIb study for IDX184 in July 2011. In January 2012, Idenix submitted interim phase IIb data for the first 31 patients to the FDA, along with a recommendation from the independent Data Safety Monitoring Board to continue the study, and requested removal of the partial clinical hold on IDX184. The partial clinical hold has now been removed allowing the initiation of dosing of an additional 30 patients in the ongoing phase IIb clinical trial and the initiation of a broad phase IIb program with IDX184 in the coming months.
About IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
Forward-Looking Statements
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C; the likelihood and success of any future clinical trials involving our drug candidates; and expectations with respect to funding of operations and future cash balances. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the Company's dependence on its collaboration with Novartis Pharma AG; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2011, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.
All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
Liver-like cells produced from an individual's own cells can support the entire life cycle of hepatitis C virus, potentially making it possible to study why people respond differently to the virus, according to a study published online Jan. 30 in the Proceedings of the National Academy of Sciences.
THURSDAY, Feb. 2 (HealthDay News) -- Liver-like cells produced from an individual's own cells can support the entire life cycle of hepatitis C virus, potentially making it possible to study why people respond differently to the virus, according to a study published online Jan. 30 in the Proceedings of the National Academy of Sciences.
Robert E. Schwartz, M.D. Ph.D., from the Massachusetts Institute of Technology in Cambridge, and colleagues examined whether hepatocyte-like cells produced by the differentiation of induced pluripotent stem cells could be infected by hepatitis C virus.
The researchers found that the hepatocyte-like cells could support the entire life cycle of the virus, including infection, replication, and production of infectious virions. In addition, infection induced an antiviral inflammatory response.
"We believe that this study lays the foundation for personalized in vitro models that can capture genetic variation of both host and pathogen, whereby induced pluripotent stem cells can be generated from identified patients with known or unknown genetic defects that impact infection," Schwartz and colleagues conclude. Abstract Full Text (subscription or payment may be required)
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Fourth Quarter 2011 Earnings Conference Call. My name is Stacy, and I will be your conference moderator for today. [Operator Instructions] As a reminder, this conference call is being recorded today, February 2, 2012. I would now like to turn the call over to Ms. Susan Hubbard, Vice President of Investor Relations. Please go ahead.
Susan Hubbard
Thank you, Stacy. Good afternoon, everyone, and welcome to Gilead's Fourth Quarter 2011 Earnings Conference Call. We issued a press release this afternoon providing earnings results for the quarter and full year 2011. Its press release is available on our website as are the slides that provide much more detail around the topics covered on today's call. I'm joined today by our President and Chief Operating Officer, John Milligan, who will review the key milestones and strategic initiatives from 2011; followed by our CFO, Robin Washington, who will provide additional details on our financial results and our 2012 guidance; Kevin Young, EVP of Commercial Operations will discuss our commercial performance; and then Norbert Bischofberger, EVP of R&D, will provide an R&D update and key milestones. John Martin, Chairman and CEO, will close out the prepared remarks by outlining our strategic initiatives for the year ahead.
As a reminder, during today's call, we will be making forward-looking statements regarding our financial outlook in addition to regulatory and product development plan. These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statement.
A description of these risks can be found on our latest SEC disclosure documents and recent press releases. In addition, please note we undertake no duty to update or revise them. We will also use non-GAAP financial measures to help you understand our underlying business performance. The GAAP reconciliations are provided in our press release as well as on our corporate website.
I will now turn the call over to John Milligan.
John F. Milligan
Thank you, Susan. Thank you all for joining us today. Our team's hard work over the last several years resulted in many significant financial, commercial and R&D milestones in 2011. We saw record revenues for ATRIPLA, Truvada, AmBisome, Ranexa, Letairis and Cayston. We also achieved record market share for our combined HIV portfolio as well as our cardiopulmonary products. Robin and Kevin will review these outstanding financial and commercial results with you and then Norbert will describe some of our many R&D accomplishments.
Single-tablet regimens are becoming the standard of care for HIV treatment, and as you know, it is Gilead's ongoing strategy to provide HIV patients with additional options for simplified regimens. During the fourth quarter, the European Commission granted approval of the Truvada rilpivirine, single-tablet regimen for the treatment of HIV. This product, marketed in the EU as Eviplera and as Complera in the U.S., constitutes our second single-tablet regimen and began launching in 2011 in the U.S., Canada, the U.K. and Austria.
Regulatory submissions for approval were made in the U.S. and EU during 2011 for Quad, which if approved will be Gilead's third single-tablet regimen for the treatment of HIV infection. The NDA was filed less than 6 weeks after data lock. These accelerated timelines for collecting and analyzing the data and filing in both the U.S. and EU were made possible by the dedication and skill of our R&D teams.
Just 2 weeks ago, FDA approved lower strength tablets and an oral powder formulation of Viread for the treatment of HIV-1 infection in pediatric patients from ages 2 to 12. We are pleased to provide this important therapeutic option for younger HIV patients and are working to make the pediatric formulations of Viread available in the U.S. and abroad.
For a number of years, we've been collaborating with various organizations to explore the use of Truvada for pre-exposure prophylaxis or PrEP. Several studies have shown that the use of Truvada in uninfected at-risk adults can reduce HIV transmission. Based on these observations, a supplemental NDA was submitted to FDA in December for the approval of Truvada for prevention of HIV infection among uninfected high-risk adults. To get expert advice on this application, FDA is determined that an advisory committee meeting for the antiviral division will be held in the May timeframe.
We continue to believe that there's room for significant innovation in the area of HIV and during the year announced a new collaboration with Tibotec to develop the first single-tablet regimen containing a protease inhibitor. Tibotec's PI, darunavir, has now been successfully combined into a single pill with emtricitabine and our investigational agents, cobicistat and GS-7340. And we anticipate clinical studies to begin later this year. In addition, a Phase II study was initiated in the fourth quarter of 2011 for a single-tablet regimen containing emtricitabine, elvitegravir, cobicistat and GS-7340.
Last year, we entered into a licensing agreement with Boehringer Ingelheim, which allowed us to combine BI's patent estate and compounds on non-catalytic site inhibitors for HIV with our internal research programs. Integrase inhibitors working by this mechanism are not expected to be cross resistant to elvitegravir and we look forward to sharing with you future data on these exciting new co-activates of the inhibitors.
On the liver disease front, 5-year data from the ongoing open label phase of our 2 Phase III clinical studies of Viread for the treatment of chronic hepatitis B represented at the key U.S. Liver Meeting, AASLD. These data showed that 5 years of Viread treatment did not just help further progression of fibrosis but actually resulted in improvement of liver fibrosis in 51% of patients and regression of cirrhosis in 74%. We continue to be enthusiastic about the prospects to help people with chronic HPV by developing finite duration treatment. With this goal in mind, an exclusive worldwide licensing and collaboration agreement with GlobeImmune was announced in October. This research is aimed at developing a therapeutic vaccine that will enhance "s" antigen conversions providing a functional cure for HPV-infected individuals. In keeping with our philosophy to develop best-in-class drugs, we acquired Pharmasset in order to bring PSI-7977 to our portfolio. We anticipate that we will be able to conduct and complete the clinical study and to allow the first approval of 7977 in combination with ribavirin by FDA during the first half of 2014. We also plan to initiate the development of alternative 7977-containing regimens, including single-tablet regimens with other candidates in our portfolio. This strategy has the potential to benefit a large number of patients and provides the opportunity for a significant revenue growth and diversification in 2014 and beyond.
Gilead's liver disease team enrolled more than 1,400 HCV-infected patients in various clinical studies during 2011, demonstrating their capacity to work towards these accelerated timelines.
In summary, 2011 was a very productive year for Gilead and I'm very proud of the individual and collective efforts of all our employees. I will now turn the call over to Rob as he discuss in more detail our financial results. Robin?
Robin L. Washington
Thanks, John. Good afternoon, everyone, and thank you for joining us. As John mentioned, we made exciting advances in our products and pipeline program, and our continued commercial execution delivered solid financial performance in spite of a challenging macroeconomic environment. For the fourth quarter, product sales were $2.1 billion, an increase of 11% year-over-year. We completed the year with total product sales at the upper end of our guidance at $8.1 billion, an increase of 10% over the prior year. At $8.1 billion, we now have a worldwide business that is 6x the size we were in 2004 when we first launched Truvada in the United States. North America product sales for 2011 were close to $5 billion in total and Europe approached the notable milestone of $3 billion. Gilead generated product revenues above $200 million in 7 countries and today have commercial operational capabilities in the U.S., Canada, Europe, Australia with a growing presence in South Korea, Hong Kong, Taiwan and Singapore. Our fiscal year 2011 non-GAAP product gross margin decreased slightly to 74.8% from 75.8% in fiscal year 2010 primarily due to an annual selling price adjustment for the percentage share of ATRIPLA that is paid to our partner. This adjustment occurred late in Q4. Compared to Q4 of the prior year, this selling price adjustment had an unfavorable impact of approximately 2% on our product gross margin.
Non-GAAP R&D expenses for 2011 were $1.1 billion, approximately $90 million above the upper end of our guidance. This was primarily due to the milestone payment associated with our accelerated registration of filings for Quad in the U.S. and Europe. In addition to the investments we made in our internal programs over the course of the year, we augmented these efforts through strategic investments and acquisitions and licensing opportunities and collaborations, which in totality resulted in additional R&D expenses for the fourth quarter and full year of approximately $60 million and $100 million, respectively.
Our 2011 non-GAAP SG&A expenses were $1.1 billion, in line with our guidance. When compared to the prior year, non-GAAP SG&A increased primarily due to expenses associated with the ongoing growth of our business, the U.S. pharmaceutical excise tax expense and bad debt provision due to slower collections in certain southern European countries.
Turning to cash flows. For the full year 2011, we generated $3.6 billion of operating cash flow, of which approximately $1 billion was generated in the fourth quarter. Our track record of generating strong operational cash flows enabled us to raise a total of $5.9 billion in debt to partially fund our acquisition of Pharmasset while maintaining our investment-grade credit rating.
The last financial highlight that I would like to share is our full year 2012 guidance, which is detailed on Slide 23 in the earnings call deck available on our corporate website. Please note that this guidance is inclusive of the Pharmasset acquisition, which closed in January. For full year 2012, we are projecting product sales of $8.6 billion to $8.8 billion, reflecting a 6% to 9% increase over 2011 product sales. This range includes the U.S. launch of Quad in the second half of 2012; the growth of Complera and Eviplera in the U.S. and Europe, respectively; the continued gains from our non-HIV products tempered by the ongoing economic uncertainties in Europe and the potential for a continued volatility in foreign currency exchange rates. For example, we estimate that a 10% fluctuation in rates or hedged currencies could have $150 million to $200 million impact on our product sales. Please note that the non-GAAP product gross margin and operating expense guidance provided to you include the impact of acquisition, restructuring and stock-based compensation related expenses where applicable.
Our non-GAAP product gross margin for the full year 2012 is expected to be in the range of 73% to 75%. We expect non-GAAP R&D expenses for the full year 2012 to be in the range of $1.325 billion to $1.4 billion. This range includes a full year operating expense impact of all our recent acquisitions, including Calistoga, Arresto, Oceanside and, most recently, Pharmasset.
We expect non-GAAP SG&A expenses for the full year 2012 to be in the range of $1.225 billion to $1.3 billion, which includes the anticipated impact of Quad launch and a higher U.S. pharmaceutical excise tax expense. Our effective tax rate for the full year 2012 is expected to be in the range of 26% to 28% due primarily to the expiration of the federal R&D tax credit and the increase in the U.S. pharmaceutical excise tax, which is nondeductible reversible.
As detailed on Slide 24, we are anticipating a full year 2012 diluted EPS impact of acquisition, restructuring and stock-based compensation related expenses to be in the range of $0.31 to $0.34 per share. And finally, we anticipate the net interest impact associated with the Pharmasset transaction to be approximately $230 million for 2012, which is detailed on Slide 25.
I'll now turn the call over to Kevin to share more review regarding our 2011 commercial performance and our outlook for 2012.
Kevin B. Young
Thank you, Robin. I am very proud of the many accomplishments achieved by our commercial organization in 2011 and our results in Q4 bode well for a successful 2012. Especially encouraging were the U.S. Truvada and ATRIPLA Q4 year-on-year growth rates of 9% and 11%, respectively. These results reflect the final release of 2011 ADAP federal funds and the resulting 50% reduction in patient waitlists from that peak. HIV product revenues were unaffected by large wholesale inventory levels and non-retail purchasing was healthy yet in line with patient demand.
The key patient drivers of HIV growth also looked very encouraging for Q3 2011, our latest data point. In the U.S., the moving annual total number of anti-retroviral-treated patient remained strong at 9% and the median CD4 count at treatment initiation hit an all-time high of 347. We have also been pleased with the uptick of Complera since its U.S. approval and launch in August of last year. Our goal of bringing the combination product of Truvada and rilpivirine to market was to provide additional options to physicians and expand the total number of HIV patients receiving a single-tablet regimen. With this in mind, I'm delighted to say that since the launch of Complera, we are seeing a 37% growth in the number of prescriptions for patients starting on a single-tablet regimen. We hope to reproduce this performance in Europe as we roll out Eviplera during 2012. To date, we have begun supplying Eviplera in the U.K., Austria and Germany.
Moving on our exceptional performance in HIV in 2011, I'm pleased to say that we have a growing business outside our core antiviral franchise. 30% of net product revenues or over $1 billion came from AmBisome, Ranexa, Letairis and Cayston in 2011. Importantly, Letairis and Ranexa had year-on-year growth rates of 22% and 33%, respectively. As I think about 2012, the underlying drivers of HIV commercial growth continue to look robust. The scientific arguments in HIV to diagnose more patients and treat them earlier have never been stronger. Moreover, the reasons to be using single-tablet regimens are compelling both medically and practically.
During 2012, we will continue to rollout Complera around the world and subject to FDA approval will bring our third single-tablet regimen to individuals in the U.S. living with HIV. We feel confident that the Quad will become an important treatment option for HIV patients initiating therapy and will ultimately be positioned as a preferred therapy in U.S. and international treatment guidelines. Like the rest of the pharmaceutical industry, we will undoubtedly continue to see some headwinds in European markets. Nevertheless, the spectionist nature of Gilead products and the strength of the pharmacoeconomic arguments to treat HIV placed us in a strong position for future growth. We will look for opportunities to open up new operating affiliates as we have done successfully in recent years in Austria, Switzerland and Poland where we see sustainable and profitable businesses and healthcare systems that support breakthrough medicines.
Finally, like the rest of my colleagues, I strongly believe that the acquisition of Pharmasset is a transformational milestone for Gilead. The worldwide potential for all oral antiviral pan-genotypic HCV cure is sizable with over 12 million infected individuals in commercial markets alone. We are already in high gear preparing global launch plans that will bring GS-7977 expeditiously to patients around the world. Our established relationships with the hepatologist and gastroenterologist via Viread HPV, our knowledge of liver disease payers and policy makers and the exciting potential of leveraging our HIV resources to expand HCV-provided capacity is a galvanizing prospect. And I am confident the Gilead commercial organization will rise to the occasion.
I will now hand the call over to Norbert Bischofberger. Norbert?
Norbert W. Bischofberger
Thank you, Kevin. For HIV, in the fall of last year, we provided positive top line results from the 2 pivotal Phase III studies comparing Quad with 2 current standard-of-care regimens, ATRIPLA in Study 102 and atazanavir boosted by ritonavir with Truvada in Study 103. In both cases, at 48 weeks, Quad proved to be non-inferior to the standard-of-care regimens. The 90% response rate observed on the Quad arm in Study 103 is the highest response rate seen in any large, blinded, randomized study of HIV patients. The 48-week results for both pivotal studies were accepted for presentation at the Conference on Retroviruses and Opportunistic Infections or CROI taking place in Seattle, March 5 through 8. Study 102 will be the subject of an oral presentation in Study 103 of a poster.
Across all our HIV programs, there will be at least 45 presentations at CROI, highlighting the important role of Gilead products in the treatment of HIV infection. In the U.S., the NDA application for Quad has been accepted by FDA for standard review with a PDUFA date of August 27. In addition, FDA indicated that a panel will be convened in the May timeframe to provide expert advice on the application. In Europe, we anticipate that EMEA will complete the review by the end of this year.
To further define the profile of the Quad, we have initiated three 48-week Phase IIIb studies to reevaluate switching of biologically suppressed patients from ATRIPLA to Quad in one study from Truvada plus a protease inhibitor to Quad and the other and from raltegravir plus Truvada to Quad in the third study. We expect data from all 3 studies to be available by late 2013. The Quad filing will be followed by regulatory filings this year for the single agent of elvitegravir and cobicistat. The filing for elvitegravir will be supported by Study 145 comparing elvitegravir to raltegravir in treatment-experienced patients. 96-week data indicating non-inferiority of the 2 arms were released in 2011.
The cobicistat filing will be supported by study 114, a Phase III study comparing cobicistat to ritonavir, both in combination with atazanavir and Truvada. We have released top line results from this study, which also met its 48-week primary objective of non-inferiority.
Last week, we announced the initiation of a Phase II clinical trial evaluating GS-7340 for the treatment of HIV infection in treatment-naïve adults. This 150-patient Phase II study will evaluate GS-7340 as a part of a once-daily, co-formulated, single-tablet regimen that will also contain cobicistat, elvitegravir and emtricitabine and will be compared to our Quad single-tablet regimen.
Moving to cardiovascular. Ranexa appears unique among anti-angina agents, because in addition to reducing ischemia in angina, there's evidence that it also lowers HbA1c, the biomarker for type 2 diabetes. 30% to 40% of coronary artery disease patients also have type 2 diabetes. Hence, these patients could potentially derive a bold benefit from Ranexa. In order to further define this potential benefit, we've initiated a Phase III program that includes 3 studies involving approximately 400 patients each to determine the effect of Ranexa alone or in combination with other antidiabetic therapies in lowering HbA1c and plasma glucose after 24 weeks of treatment. Confirmation of the antidiabetic effect of ranolazine in these studies could lead to a new indication of ranolazine for the treatment of type 2 diabetes.
Another opportunity for Ranexa is it's used in conjunction with percutaneous coronary intervention or PCI to prevent subsequent major adverse outcomes. A subgroup analysis of MERLIN, a 7,000-patient study of Ranexa in acute coronary syndrome indicated that Ranexa treatment resulted in a reduction of major adverse cardiovascular events in patients with a history of angina undergoing PCI. A Phase III study has started to further define the potential benefit of Ranexa post-PCI. In this trial, 2,600 patient with the history of angina undergoing PCI with incomplete revascularization will be randomized to Ranexa or placebo with the end point of major adverse cardiovascular events.
On the oncology front, in further strengthening of R&D management, Roy Baynes has joined the Gilead team as Senior Vice President, Oncology Therapeutics. Roy joined us from Amgen where he served as Vice President, Global Development and Therapeutic Area Head for Hematology Oncology. Throughout his tenure there over the last decade, he helped the Clinical Development and Medical Affairs teams responsible for the approval and launch of numerous hematology and oncology products.
Gilead has acquired promising oncology assets over the last couple of years and voice leadership will be important in bringing these novel candidates to market. GS-1101 went into Phase III development this quarter with studies in chronic lymphocytic leukemia. In addition, patients are being involved in 3 Phase II studies of the monoclonal antibody, GS-6624. These Phase II studies are evaluating the efficacy and safety of 2 different doses of GS-6624 in myelofibrosis, pancreatic and colorectal cancers. The pancreatic and colorectal cancer studies are both randomized, blinded studies comparing 6624 versus placebo when added to the standard of care in second line metastatic disease. In addition, 6624 is also being evaluated in a Phase Ib study in IPS and in a Phase II study for liver fibrosis and HCV-infected patients.
And finally, turning to liver disease. John, Robin and Kevin have all mentioned the important acquisition of Pharmasset. We are proceeding with the Pharmasset Phase III development plan for GS-7977 in genotype 2 and 3 patients. This program consists of 2 studies, 1 in treatment-naïve patients with patent interferon ribavirin as the control arm, the second in interferon intolerant in eligible patients with placebo as the control arm. I'm pleased to report that the treatment-naïve study was initiated in mid-December, and since then, we have screened 145 patients. This trial is the rate-limiting study for filing because of the 24-week duration standard-of-care arm. Due to the great interest and fast enrollment, we anticipate that these 2 Phase III studies will reach target enrollment in the United States before we will be able to activate sites in other geographies.
As you know, results from the ELECTRON study were presented by Pharmasset at AASLD last October where GS-7977 and ribavirin for 12 weeks resulted in 10 out of 10 cures in genotype 2/3 patients. We're awaiting data from multiple studies in genotype 1 patients specifically from the ELECTRON study, which involve genotype 1, both treatment-naïve and null responders, as well as on the QUANTUM study, which involve genotype 1 treatment-naïve patients. We received news this week that our late breaker abstract has been accepted to CROI for 2 cohorts of genotype 1 HCV-infected patients from the ELECTRON study null responders and treatment naïve patients. In both cohorts of that study, all patients treated with GS-7977 and ribavirin achieved undetectable viral load at 4 weeks on treatment, also known as rapid biological response or RVR.
By the time we present those results, we will have 4 weeks of staying by watching for the response data or SVR4 from the nonresponder patients. Many of you noticed, but it's important to reiterate that RVR reflects biological response on treatment. However, the important measure of response and the accepted Phase III endpoint is SVR12, which is a sustained biological response 12 weeks after end of treatment. SVR4 data are a reasonable proxy for SVR12 as most patients that rebound after treatment discontinuation do so in the first 4 weeks.
We also anticipate that we will have a significant presence at the European Liver Conference taking place in Barcelona in April with over 17 submitted abstracts from our HCV effort alone. As Gilead has pioneered in HIV, we expect to bring forward next generation single type of regimens for the treatment of hepatitis C also. To that end, drug interactions will be carried out with 7977 and GS-5885 and other internal candidates, which will be followed by Phase II clinical studies.
In closing, the investments we're making today, both in our broad and promising internal R&D efforts we have embarked upon, will continue to drive the success of our business in the future. I would now turn over the call to John Martin. John?
John C. Martin
Thank you, Norbert. As you have heard, we met a number of important milestones in 2011 that were achieved as a result of all the hard work of Gilead employees over the last several years. This momentum is continuing into 2012. For HIV, we will continue to benefit from the evolution of the U.S., European and international guidelines that support earlier diagnosis and treatment as well as the growing appreciation for the benefits provided by single-tablet regimens. In 2006, the Centers for Disease Control and Prevention suggested HIV testing as part of routine medical care in order to decrease the incidence of new infections. This benefit has now been quantified in study HPTN 052, demonstrating that HIV treatment results in 96% reduction of HIV transmissions in serodiscordant couples. The publication of this work in the New England Journal of Medicine was recognized in December as the Breakthrough of the Year by Science Magazine. The high efficacy demonstrated in HPTN 052 has ended the debate on the value of treatment as prevention.
In summary, we look forward to adding to the strength of our HIV business with our growing pipeline in cardiopulmonary, oncology and liver disease. As we enter our 25th year, I believe that the health of our company has never been stronger with prospects for exceptional growth for many years to come.
Idenix put out the news this morning that the FDA had lifted a partial hold on its hepatitis C drug IDX184--and then watched its share price slide.
In a sign of just how volatile the whole hepatitis C arena has become after back-to-back blockbuster buyouts, the key focus today is on Gilead's ($GILD) surprise acknowledgement that its new hep C favorite scored promising numbers for the genotype 1 patient population. Indenix ($IDIX) and Achillion ($ACHN)--the other biotech most frequently mentioned as a likely takeover target--suffered from the comparison.
"After review of the interim safety and antiviral activity results from the IDX184 phase IIb clinical trial, the FDA removed the partial clinical hold and has allowed us to continue enrollment of this study," says Idenix CEO Ron Renaud. "Importantly, this allows us to expand the phase IIb program and evaluate IDX184 in interferon-free combination regimens with other direct-acting antivirals. We are working toward beginning all-oral combination trials as quickly as possible."
Expanded trial, all oral, interferon-free--all good things in the hepatitis C world.
As MarketWatch noted a couple of days ago, investors have been bidding up shares of Idenix and Achillion in the hope that they can profit from some other premium buyout. William Blair analyst Katherine Xu told the wire service that any Idenix buyout would likely be put on hold until after that pesky partial hold was lifted. But for a few hours anyway, Idenix's good news can't compete with promising data from Gilead.
- read the press release- get the story from MarketWatch
Gilead Sciences Inc. (GILD), the drugmaker that acquired Pharmasset Inc. last month for its experimental hepatitis C treatments, gained in extended trading after saying one of the therapies produced positive clinical trial results.
Patients with genotype 1 hepatitis C -- the most common in North America -- had no detectable signs of the virus after four weeks on the drug, PSI-7977, Norbert Bischofberger, Gilead’s chief scientific officer, said today on the Foster City, California-based company’s earnings call. An earlier study of the medicine, gained in the $10.8 billion Pharmasset purchase, cured all patients with genotype 2 and 3.
Drugmakers including Gilead, Merck & Co., Vertex Pharmaceuticals Inc. and Bristol-Myers Squibb Co. (BMY), are striving to develop a new class of oral cures for hepatitis C to replace older drugs that require injections. Bristol-Myers recently agreed to spend $2.5 billion to buy Inhibitex Inc. (INHX) for its experimental hepatitis C therapies.
“It looks like Gilead will race ahead and continue to lead because its drug 7977 continues to support potential 100 percent cure rates,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, said in an interview. “The data disclosed in genotype 1, an important population for which there was no good data yet, continues to show they can support a multibillion-dollar drug franchise with 7977.”
The drug was tested in combination with ribavirin, a medication currently used in treating the disease. The therapy was given to patients who hadn’t taken other drugs and those whose illness wasn’t helped by other treatments.
The company will present further data on the clinical trial at an infectious diseases conference next month in Seattle.
Gilead rose as much as 6.4 percent to $52.45 after closing at $49.31 in New York trading.
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Fri, Feb 3, 2012
An experimental drug combination to cure hepatitis C has produced positive clinical trial results, revealed Gilead Sciences during its quarterly conference call.
The announcement overshadowed the company's 4th quarter earnings and outlook which were mostly disappointing.
The company's chief researcher, Norbert Bischofberger, disclosed that genotype 1 hepatitis C patients treated with the combination of experimental pill GS-7977 and ribavirin showed no signs of the virus after four weeks of treatment.
The results put Gilead ahead of other drug companies looking for a way to replace injections with an oral regimen against hepatitis C. The same treatment was already known to be effective against genotypes 2 and 3. Gilead had acquired the rights to GS-7977 (formerly PSI-7977) through its $10.8 billion acquisition of Pharmasset.
More clinical trial data will be presented by Gilead at an infectious diseases conference next month in Seattle. Analysts note that the drug combination still needs to be submitted to the FDA for approval.
Left untreated, the hepatitis C virus can cause liver damage. It is the main cause of liver transplants in the United States.
Headquartered in Foster City, Gilead Sciences is a major biopharmaceutical company known its portfolio of drugs that treat HIV infections, liver disease and cardiovascular and respiratory ailments.
PARIS, February 3, 2012 /PRNewswire via COMTEX/ -- 'SARAH' - a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma is now open for recruitment
The start of SARAH, a new randomized controlled trial to directly compare the effectiveness of radioembolization with yttrium-90 resin microspheres (SIR-Spheres® microspheres; Sirtex Medical Limited, Australia) versus sorafenib (Nexavar®, Bayer HealthCare Pharmaceuticals, Germany), a systemic therapy that is the current standard of care for patients with non-surgical advanced hepatocellular carcinoma (HCC), was announced today by the principal investigator, Professor Valérie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris, Clichy and Université Paris Diderot, Sorbonne Paris Cité, France.
SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma)is a Phase III multi-centre prospective randomized open-labelled trial, which aims to recruit 400 patients in France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, who are ineligible for surgical resection, liver transplantation or radiofrequency ablation; or whose disease has progressed or recurred after previous therapies.[1]
The primary goal of the study will be to assess if radioembolization with yttrium-90 resin microspheres provides an increased survival benefit compared to sorafenib in patients with advanced HCC.
Professor Vilgrain said: "Around 20 specialist cancer centres throughout France will be involved in this trial. SIR-Spheres microspheres were selected for the test arm of this collaborative trial, which is being promoted by the 'Assistance Publique - Hôpitaux de Paris'."
In patients with advanced HCC, sorafenib is now the standard treatment. Its use is associated with an increased median overall survival (from 8 to 11 months in the SHARP trial) but 80% of patients also experience treatment-related adverse events.
Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumours. It is a minimally-invasive treatment, in which millions of radioactive SIR-Spheres microspheres (diameter between 20-60 microns) are infused via a catheter into the liver, where they selectively target liver tumours with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue. There is a growing interest in radioembolization using yttrium-90 resin microspheres in this patient population, based on a substantial number of open-label single-group studies as well as a large multi-centre European analysis[2] of the long-term outcomes related to survival and safety of radioembolization using SIR-Spheres microspheres in patients with inoperable HCC. In 13 open-label single-group studies totalizing 400 patients with advanced HCC, the combined estimation of the median overall survival after radioembolization with yttrium-90 microspheres was of 15 months (min-max:7 to 27 months).
SIR-Spheres microspheres are approved for use in Australia, the European Union (CE Mark), New Zealand, Switzerland, Turkey and several other countries including in Asia (e.g. India, Korean, Singapore and Hong Kong) for the treatment of unresectable liver tumours. SIR-Spheres microspheres are also indicated in the U.S. for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.
Professor Vilgrain said that: "The SARAH trial is testing the hypothesis that radioembolization using yttrium-90 resin microspheres can increase the median overall survival with fewer side effects and/or a better quality of life in comparison with sorafenib. We hope that the results of this study will help improve the prognosis for these difficult to treat patients".
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis and alcoholism. It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the third-leading cause of cancer deaths.[3] It occurs with greatest frequency in regions where viral hepatitis B or C aremost often diagnosed, such as in Asia Pacific and Southern Europe.
Hepatocellular cancer can be cured by surgery, either by resecting the diseased parts of the liver, or by transplantation with a liver from a healthy donor. These interventions, however, are inappropriate for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour invasion.
References:
SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442.
Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY). Survival after [90]Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation.
Hepatology 2011; 54: 868-878.
GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008. http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011
SOURCE Sirtex Medical Limited
Copyright (C) 2012 PR Newswire. All rights reserved
A team of scientists from the University of Utah and the University of California at San Francisco has discovered that the mutation of a gene encoding a ketone body transporter triggers accumulation of fat and other lipids in the livers of zebrafish. This discovery, published in the Feb. 1, 2012, issue of Genes & Development, reveals that transport of ketone bodies out of the liver is a critical step in energy metabolism during fasting. It also provides a new approach for studying the development of fatty liver disease in humans.
Nonalcoholic fatty liver disease (NAFLD), or abnormally high accumulation of lipids in the liver, is the most common cause of chronic liver disease worldwide. Lipids are a broad group of molecules that include fats, triglycerides, and cholesterol. In some people, NAFLD causes no complications, but in others, excess fat in the liver can lead to inflammation or development of scar tissue, resulting in permanent liver damage or even liver failure. NAFLD may also increase the risk of heart disease in people who are overweight or obese. The increasing prevalence of NAFLD in the United States is due, in large part, to the obesity epidemic and it is estimated that more than 6 million U.S. children already have fatty liver disease.
"Currently, there are a limited number of treatment options for decreasing excess fat in the liver and there are no methods for reversing damage to liver tissue due to NAFLD," says Amnon Schlegel, M.D., Ph.D., investigator in the University of Utah Molecular Medicine program, assistant professor of internal medicine at the University of Utah School of Medicine, and senior author on the study. "By identifying and characterizing novel genes that regulate accumulation of lipids in the liver, we may be able to gain new insight into the physiological processes that lead to NAFLD."
Previous research has shown that many of the proteins known to control lipid metabolism in humans are also present in zebrafish. Schlegel and his colleagues began by identifying a zebrafish mutant known as red moon (rmn), which developed abnormal lipid accumulation in liver cells, without evidence of associated liver inflammation or liver damage, when exposed to fasting conditions. Schlegel and his colleagues then used a molecular genetic technique called positional cloning to isolate the gene disrupted by the rmn mutation. They found that the rmn mutation inactivated slc16a6a, a gene thought to encode a protein required in the transport of nutrients during fasting.
"Until now, the activity of the Slc16a6a protein has not been functionally characterized in any organism," says Schlegel, who's also an adjunct assistant professor of biochemistry at the U medical school. "Our studies indicate that Slc16a6a is a protein involved in the transport of β-hydroxybutyrate."
β-hydroxybutyrate is a ketone body, a compound that is produced in the liver when blood glucose is low and fatty acids are broken down for energy. During periods of fasting, most body tissues can use fatty acids as an energy source, but the brain relies on β-hydroxybutyrate and other ketone bodies for fuel. Schlegel and his colleagues discovered that, in rmn mutants deprived of nutrition, loss of Slc16a6a function disabled secretion of ketone bodies from liver cells and increased lipid accumulation in the liver. They also found that introducing the human form of the SLC16A6 protein into rmn mutant livers restored ketone body secretion.
"Our research has uncovered a previously unrecognized, but critical step, in the complicated physiology of fasting," says Schlegel. "We still don't know whether altered fasting liver metabolism influences the development of NAFLD, but knowing that Slc16a6a is required for secretion of ketone bodies from liver cells during fasting may have implications for our understanding and treatment of other medical conditions where ketone bodies play a role. These include uncontrolled type 1 diabetes, obesity, and childhood metabolic disorders caused by defects in fatty acid metabolism."
Study finds biomarker to be more accurate than traditional cholesterol risk factors in predicting stroke
NEW YORK, February 2, 2012 – Postmenopausal women may be at higher risk of having a stroke than they think.
A new study by researchers at NYU Langone Medical Center and colleagues found that traditional risk factors for stroke – such as high cholesterol – are not as accurate at predicting risk in postmenopausal women as previously thought. Instead, researchers say doctors should refocus their attention on triglyceride levels to determine which women are at highest risk of suffering a devastating and potentially fatal cardiovascular event. The study appears online today in the journal Stroke.
"Every year, hundreds of thousands of people are affected by stroke and there is a tremendous emphasis on identifying people at increased risk," said lead author Jeffrey S. Berger, MD, assistant professor of medicine and director of Cardiovascular Thrombosis at NYU School of Medicine, part of NYU Langone Medical Center. "This study revealed that what we've been using to evaluate risk all these years actually has little to no predictive value in older women. Triglyceride levels, however, take on a new significance. "
According to the U.S. Centers for Disease Control and Prevention, nearly 800,000 Americans suffer a stroke each year. Ischemic strokes, the type assessed in this study, account for more than eight out of every ten strokes. They occur when blood clots, developing from high levels of a waxy substance in the blood called cholesterol, obstruct blood vessels to the brain. Cholesterol is made up of several lipids, or lipoproteins. Triglycerides are one type of such a lipoprotein, while others include low-density lipoproteins (LDL) and high-density lipoproteins (HDL)."
"We've always believed that total cholesterol and LDL cholesterol levels were the most important biomarkers for identifying stroke risk, but this study gives us strong evidence to question that approach," Dr. Berger said.
The researchers analyzed data from the Hormones and Biomarkers Predicting Stroke (HaBPS) study, consisting of women enrolled in the Women's Health Initiative (WHI), a landmark National Institutes of Health-sponsored study that has monitored the health of more than 90,000 postmenopausal women nationwide for more than 15 years. HaBPS is comprised of the first 972 women who experienced an ischemic stroke while participating in the WHI. These women were matched with a control group of 972 participants who had not had strokes. All the women had donated blood samples when they first enrolled in the WHI, and these samples were then analyzed for differences in lipid biomarkers.
The most compelling finding, according to Dr. Berger, was that high triglyceride levels were significantly associated with the development of stroke. In fact, women in the highest quarter of baseline triglyceride levels were nearly twice as likely to have suffered an ischemic stroke as women in the lowest quarter of triglyceride levels during the course of the study. Surprisingly, LDL cholesterol and total cholesterol, however, were not associated with stroke risk in this population, despite their perceived value in the medical community.
Whether the strong association between triglycerides and stroke would also be seen in other populations is still unknown. "This is only the first step. It's a really important step, but it's not the end of the story," Dr. Berger said. "While this study identifies subjects at increased risk of ischemic stroke, the long term goal is to reduce that risk. Future studies aimed at lowering triglyceride levels for reducing the risk of stroke are warranted."
About NYU School of Medicine:
NYU School of Medicine is one of the nation's preeminent academic institutions dedicated to achieving world class medical educational excellence. For 170 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Medical Center, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research and direct patient care. The School also maintains academic affiliations with area hospitals, including Bellevue Hospital, one of the nation's finest municipal hospitals where its students, residents and faculty provide the clinical and emergency care to New York City's diverse population, which enhances the scope and quality of their medical education and training.
Additional information about the NYU School of Medicine is available at http://school.med.nyu.edu/. Inspirational
(CBS/AP) Nine-year-old Alannah Shevenell is home from a Boston hospital with six new organs. The 9-year-old Maine girl received a new stomach, liver, spleen, small intestine, pancreas, and part of an esophagus to replace the ones that were being choked by a huge tumor. It's believed to be the first-ever transplant of an esophagus and the largest number of organs transplanted at one time in New England.
In 2008, Alannah, then 5, began running a fever and losing weight while her belly swelled. Doctors discovered a tumor that year and twice attempted to remove it, as it made it spread from organ to organ. But it was difficult to reach what turned out to be a rare form of sarcoma, said Debi Skolas, Alannah's grandmother, and chemotherapy didn't do the trick.
The growth - known as an inflammatory myofibroblastic tumor - continued to grow in her abdomen, causing pain, making it hard to eat and causing Alannah to swell up with fluid. Surgery was the last resort to save her life, and Alannah spent more than a year on a waiting list for the organs, said Dr. Heung Bae Kim, the lead surgeon on the procedure at Children's Hospital Boston.
The family was told there was a 50 percent chance Alannah wouldn't survive the procedure - but without it, she had no chance whatsoever.
In October, doctors prepared to remove the growth and the organs in one fell swoop and replace them with organs transplanted in one tangled piece from another child of similar size.
The hardest part was taking out her organs and the tumor, Kim said, calling it a difficult operation with lots of blood loss.
"It's probably one of the most extensive tumor removals ever done," the surgeon said.
Dr. Allan Kirk, professor of surgery at Emory University in Atlanta and the editor-in-chief of The American Journal of Transplantation, said no other esophageal transplant has been reported in medical literature.
After the surgery, Alannah spent three more months at the hospital. She battled infections and complications from the surgery before finally being given the OK to leave.
Healthy, active, and with high hopes, Alannah said Thursday that she's glad to be feeling well again and able to go sledding, make a snowman, work on her scrapbooks and give her grandmother a little good-humored sass.
The best part? "Being home," she said. "Just being home."
Even at home, Alannah has to take nine medications each day, some two, three or four times. Her grandparents have to precisely measure what goes in and comes out of her body, and check her blood sugar.
She has an ostomy pouch - a prosthetic device that collects waste - and a feeding tube attached to her for nutrition as she slowly gets used to eating again.
Her immune system is so weak that she can't go to places with large numbers of people. She can't eat raw vegetables or fruits unless they have thick skins because of concerns over germs, and she'll never be able to swim in a lake because of the bacteria.
WebMD has more on organ transplants.
After a certain fast food chain was linked to an outbreak of salmonella that sent at least 20 people to the hospital last year, food safety officials decided it wasn't necessary to tell consumers which restaurant was allegedly involved.
In fact, in dozens of cases after the outbreaks were over, the Food and Drug Administration and Centers for Disease Control kept the names of restaurants that were part of investigations secret, apparently for fear of damaging their relationships with the companies...
In the most recent case, Food Safety News revealed Wednesday that a mysterious "Mexican-style" restaurant chain linked to an October 2011 salmonella, only identified as "Restaurant Chain A" in official documents, was actually the popular fast food restaurant Taco Bell.
