Food scientists suggest that boiling shrimp may reduce shellfish allergens

Food scientists suggest that boiling shrimp may reduce shellfish allergens

A study published in the Journal of Food Science shows that food scientists found that boiling shrimp for 10 min may reduce allergenic properties of total shrimp extracts. Food allergies, especially shellfish allergies, can lead to severe reactions, including life-threatening anaphylaxis. Shellfish is the number one cause of food allergy in adults in the United States and is responsible for the majority of emergency department visits. More than 1 in 50 Americans have been diagnosed with shellfish allergies, so they tend to avoid it at all costs. Tropomyosin (TM), a major allergen in seafood that triggers allergic reactions, is likely to be a better tool for the diagnosis of shellfish allergy than the total extract.

Researchers from Jimei University in Fujian, China and the Agricultural Research Service in New Orleans, La. examined shrimp extracts from both raw and boiled shrimp, which were ground and then freeze-dried. The research showed that boiling shrimp may decrease the presence of antibodies that cause an allergic reaction.

“Understanding the allergenic properties of shrimp as affected by the cooking process is critical for shrimp allergic individuals,” said lead researcher Guang Ming Liu. “Our research shows that TM seems to be an effective antigen in diagnosing shrimp allergy.”

I think the Flu season wasn’t overhyped rather I think all the attention changed people’s behavior


This article in Wall Street Journal seems to say that H1N1 was overhyped. I think it wasn’t overhyped, rather, I think all the attention it was given changed people’s behavior which lowered the size of the outbreak. Also remember that this flu killed more children than any flu in over 75 years.

This has been a flu season like few others.

Normally at this time of year, influenza is rampant in the U.S., prompting hundreds of thousands of people to stay home in the dead of winter with fever, aches and pains.

Now, after raging through college campuses and communities last summer and fall, cases of the new H1N1 swine flu virus have dwindled to a trickle, and run-of-the-mill seasonal flu has barely made an appearance. Not one state reported widespread flu illness to the Centers for Disease Control and Prevention for the week ended Feb. 20, the latest data available. The percentage of all doctors’ visits by patients with influenza-like symptoms has dropped from a high of 7.8% in late October—the largest peak since the agency began surveillance in 1997—to 1.8% in late February, well below the norm for flu season.

Doctors and flu experts say the lull is unusual. “This is typically the peak of flu,” said James Turner, executive director of the University of Virginia’s department of student health. He said the Charlottesville, Va., student health center usually sees as many as 130 students a week complaining of flu symptoms this time of year. Recently, no more than three to five students a week have been coming in with fever, cough or other signs of flu, he said.

It is not clear why there is so little flu, particularly swine flu, going around, experts say. “Surely there’s a sufficient number of people who haven’t been infected or vaccinated,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

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More interactive graphics and photos Many scientists say the answer probably has to do with how the flu virus progresses. Influenza comes and goes in waves, normally running from October through May. But pandemic viruses—new viruses that emerge and spread quickly around the globe—often move to a different rhythm, and can reach their busiest stage at unusual times like summer and early fall, although the reason for this isn’t understood. Flu has peaked in late February or early March in 20 of the past 26 flu seasons, said Lyn Finelli, the CDC’s chief of flu surveillance and outbreak response. But the latest swine flu wave started in August, and peaked in late October, before waning.

Widely publicized preventive measures such as hand washing, and the large national vaccination effort thus far, may also have played a role in the sharp drop off in H1N1 infections, but it is not clear by how much, said Anthony Fiore, a medical epidemiologist with the CDC’s influenza division.

By mid-January, swine flu had sickened about 57 million people in the U.S. and killed roughly 11,700—mostly young adults and children—from the time it emerged in late April through mid-January. Young people who ordinarily fight off flu easily ended up in intensive care units on advanced life support. Pregnant women, children, and other people at risk of flu complications stood in line for hours for vaccine, as slow production and delays prompted limited supplies.

In past years, when seasonal flu was the big worry, influenza has typically sickened about 25 million people a year, and directly killed about 8,000, according to the CDC.

The H1N1 flu virus hasn’t disappeared, and another wave could still come this winter. “We’ve had peaks [of flu] as late as May, so we’re not out of the woods yet,” said Dr. Fiore of the CDC’s influenza division. The virus could also mutate, spawning more new infections, though it hasn’t done so yet. Flu experts estimate that more than half the country’s population may still be vulnerable to the H1N1 virus, either because they haven’t been sick or gotten vaccinated.

Some recent statistics could be warning signals. A few states have reported small increases in the percentage of doctors’ visits by patients with flu-like symptoms. And the American College Health Association reported for the week ending Feb. 19 its first uptick in swine flu cases on college campuses since mid-December, to 4.1 cases per 10,000 from 2.7 cases per 10,000.

Dr. Turner, who is also president of the ACHA, said the organization plans to decide along with the CDC after getting more data this week whether to warn colleges to promote prevention measures to thwart a new wave that may be on its way. He said he is concerned that college students traveling on spring break could bring the disease back with them to campus. “If there’s anytime we’re going to see an increase in disease activity, I’d say March or early April is the time,” he said.

Flu Gazing
What’s expected for the future of the H1N1 swine flu virus.

Flu experts say it is impossible to know if or when there will be another wave of swine flu.The flu season may not be over for this year, and swine flu could still return in strength. At least half the population remains susceptible to the flu.Some scientists expect any return of the virus won’t be as severe as last fall. Millions of people are immune now, either because they were sick or have been vaccinated. Vaccine for H1N1 swine flu is still being administered, and next year’s shot will include protection against the strain, along with two other seasonal viruses. Another possibility: The H1N1 virus could mutate and make the current vaccine, as well as next fall’s version, less effective.U.S. and global health officials have recommended that the new H1N1 virus be included as one of three strains in next season’s flu vaccine. The CDC’s vaccine advisory panel also expanded its recommendation for who should get flu shots to include young and middle-aged adults, among whom death rates from the new H1N1 virus have been higher than for the elderly or children. The change means that all Americans now will be encouraged to get flu shots when the next vaccine is ready in September.

The unusual course this flu season is taking isn’t one that public health officials are eager to repeat. Not knowing when the next flu outbreak could occur will mean staying on high alert for much of the year. It would also mean another rush to get vaccine distributed quickly. The CDC, which normally starts tracking flu hospitalizations and deaths in October, will continue to monitor them this spring, summer, and early fall. “We’re going to make sure when it hits, we know about it and can describe it,” Dr. Finelli said.

Associated Press

Jack Houley, 10, received a shot of the H1N1 vaccine in Annapolis, Md., last August.
Nancy Cox, the CDC’s influenza chief, told a vaccine advisory panel last week that the pandemic H1N1 virus is likely to eventually become a seasonal strain, though it is not one yet. Globally, the pandemic virus is still circulating in tropical countries and some parts of Europe, but is waning in most places, according to the World Health Organization.

Flu experts say they don’t know why there is so little seasonal flu circulating this year. One theory doctors are debating is that people infected with H1N1 swine flu may produce a chemical in their bodies that protects them against other flu viruses.

The new virus doesn’t appear to have completely muscled out other flu viruses, as some past pandemic viruses have. While one seasonal strain appears to have succumbed to the new tide of H1N1, another that is considered particularly hard on the elderly—H3N2—has continued to circulate in pockets of the globe, albeit in small amounts.

While relatively few people are currently seeking out H1N1 shots, the CDC isn’t giving up on promoting the vaccine this winter. About 155 million doses of H1N1 vaccine have been distributed so far this flu season, and about 86 million people have been vaccinated—a few million less so far than normally get vaccinated for seasonal flu. The agency is especially urging parents with children under 10 who have only had one dose to get a second, which it says is needed for full protection.

Even if a new wave of H1N1 illness occurs, some experts believe it won’t be as large as the one last fall.

That’s because millions more people have become immune either through infection or vaccination. “I think we’ll have scattered outbreaks in communities that didn’t have it,” said Dr. Finelli.

US Soldier returns from Haiti with rare bacterial infection

U.S. Army Warrant Officer Chris Lust at the V.A. Hospital in Tampa. His mother says he has a blood clot in his hand and he is battling a rare bacterial infection.
STUART, FL — U.S. Army Warrant Officer Chris Lust of Stuart is recovering from a rare bacterial infection which he contracted while helping with the earthquake relief efforts in Haiti.

Lust says he was helping distribute food to earthquake victims in Port-au-Prince when he became ill.

“Real bad body aches…right before I experienced spiking temperatures, from 103-105….I was getting real cold…cold sweats…and I get so cold I started shaking,” said Lust, speaking from his hospital bed at the James A. Haley Veterans Hospital in Tampa.

He says he was flown to the U.S. Navy ship Comfort, anchored off the coast of Port-au-Prince, for treatment.

At first he was told he suffered from dengue fever, or possibly malaria. But when he arrived at the VA hospital in Tampa, doctors changed the diagnosis to leptospirosis, he said.

According to the World Health Organization leptospirosis is a rare and severe bacterial infection that is endemic in Haiti. The WHO reports infection in humans may occur when the bacteria come into contact with the skin, typically through contact with unclean water that has been infected by animals.

“It’s kind of like they’re writing a blank check when they go into these places and it might cost them their life,” said Lorilei Lust, Chris’ mother.

She visited her son at the VA hospital and said he experienced seizure-like symptoms and painful headaches.

Lust was transferred out of the I.C.U. on Saturday. He says doctors plan to fly him to San Antonio for follow-up care within the week when he’s able to make the move.

U.S. Army spokesperson Gary Tallman said he could not comment on this case as it would violate personal privacy laws. When asked if other soldiers have become ill following service in Haiti, Tallman said he would try to find out.

What’s good for the goose – Goose eggs for manufacturing Avian influenza vaccines


Feb. 20–RURAL TOLNA, N.D. — As Rick Glynn and Spencer Hanson walk on a soft layer of straw, scores of geese — a few honking at the excitement — waddle out of their way, some strolling to another part of the indoor pen, others sauntering outside into the crisp, bright February morning sun.

“They can go in and out as they want. They do real well in winter,” Hanson said of the free-range birds. “Each one has its own goose down coat,” Glynn added. Tolna, once called the “turkey capital” of North Dakota, is quickly becoming the “goose capital,” since Schiltz Foods and Goose Farms, based in Sisseton, S.D., brought 8,000 breeding geese to a converted turkey barn here two years ago.

Schiltz remodeled the barns and did some building. Commercial geese facilities are not as crowded as turkey or chicken barns. Each goose requires at least 5 square feet of space. The barns and outdoor pens are divided to keep different bloodlines separated. The move to Tolna was prompted partly by an outbreak of West Nile virus in 2002 that claimed 30 percent of the geese at the Sisseton farm, which accounts for about 80 percent of the nation’s domestic goose supply. The company wanted to separate its breeders from the rest of the operation, to ensure that the company does not suffer such a devastating blow again.

Schiltz also embarked on a research mission to find a vaccine in 2005. Today, the company is on the leading edge of research to create a vaccine for West Nile virus. It’s made from antibodies drawn from goose eggs. The company’s Interglobal Biologics Inc., a biotech subsidiary, has joined with the UND Research Foundation to create a company called Avianax to develop antibodies and vaccines to protect against viral, infectious diseases — specifically West Nile Virus and Avian Flu.

Avianax is establishing a laboratory at UND’s REAC 1, a 50,000-square-foot research and development hub that houses eight businesses, said Jim Petell, executive director of UND Research Foundation. REAC, which stands for Research Enterprise and Commercialization, provides Biosafety Level 3 laboratories for the sensitive studies. The principal scientist at Avianax is Dr. David Bradley, an assistant professor in UND’s microbiology and immunology department. Bradley also is working with Dr. Gregory Poland at Mayo Clinic in Rochester, Minn. Poland, who is American editor of the medical journal Vaccine, is an internationally known expert in therapeutic vaccines.

The company is conducting “pre-clinical” studies, to determine what is called “proof of concept” by the U.S. Food and Drug Administration, said Jim Schiltz, Schiltz Foods president and CEO. “After that, if all testing proves positive and we get FDA approval — and that is a ‘big IF’ — you are looking at four to six years for creating such a facility and having it engage in such production,” he said.

“There is no reason to believe the antibodies can’t treat more diseases,” he said. “It all depends on what the researchers find. There is potential to expand beyond West Nile and H1N1 flu is an example.” Additional research could result in antibodies and vaccines to help pharmaceutical companies develop drugs to treat other medical issues, such as high blood pressure or high cholesterol.

Avianax officials said it could take as many as 1 million eggs to realistically produce antibodies or vaccines. Goose eggs make sense, Schiltz said. They have as much as five times the volume of chicken eggs. Each goose egg can produce as many as two doses of vaccine. In comparison, it takes two to three chicken eggs to produce one dose of vaccine. 300,000 eggs Schiltz Foods could have moved its breeding operation anywhere in the region. But officials picked Tolna for a couple of reasons. One is the location. It’s just 90 miles from Grand Forks, rather than the 170 miles between Sisseton and Grand Forks. Another is that it has turkey farms that can be converted to goose farms. The company bought its first farm from a retiring turkey farmer who lived west of Tolna, in Benson County. It recently completed converting a second turkey farm, which closed in 1994. Tolna city officials paid to keep heat in that facility for 15 years, to make it available for a new economic enterprise.

It’s just about the peak season for goose eggs. About 75 percent of the geese are female, which lay eggs in late winter and spring. Each female will lay about three dozen eggs per year, bringing the total of the 8,250 laying geese to almost 300,000 eggs a season, which lasts until mid-July. The eggs are shipped to Sisseton. Slightly more than half of the eggs will hatch and develop into goslings. Some will be held back as replacement breeders. Others will be shipped, at an average weight of 16 pounds, to the Sisseton facility, to be processed and sold. A 16-pound goose will produce about 11 pounds of meat.

The company markets the goose meat throughout the country, especially to the East and West coasts, where it is a popular holiday meal, especially with people of Eastern European descent, said Glynn, a Schiltz Foods representative. Economic boost The combined operation now has about 11,000 breeding geese and employs about 10 people, including those who travel to Tolna just for the peak egg season and a driver who hauls eggs to Sisseton every day. While some employees are area residents, others are moving to the region, said Bob Engen, a Tolna businessman and economic development leader. Hanson moved his family here two years ago from Sisseton. Glynn, who lives in Sioux Falls, S.D., plans to move his family to the area this spring or summer. He and his wife, Pauline, who also works at Avianax in Grand Forks, have been commuting.

“It’s one more thing that adds to the economic mix. It’s good for the community,” he said. “More people are eating lunch in the cafe. They’re buying groceries. They’re attending schools.” It could grow even more, if things work out, from additional breeding and egg-producing barns, to other ventures. The company is working toward the possible future construction of a pathogen-free facility and possibly a satellite lab at the Tolna farm. That, Schiltz said, would be an FDA decision that could be a year or two away. If it happens, employment likely would grow substantially with highly skilled workers, although it’s too early to make job-creation projections, Schiltz said. “It has been my experience that you need to pay whatever is needed to get the skill set the job requires to accomplish the task in an error-free manner, especially when trying to run a facility of this nature,” Schiltz said. “What is the average wage in North Dakota? I would guess these would be above that.” After two years here, company officials are convinced they made the right move. “We really like Tolna, and the geese are exceptionally happy,” Schiltz said. “There are such nice trees that cut the wind in the winter and provide cool shade in the summer.” Geese do not like hot weather. “The land itself drains, and we do not end up with muddy conditions, again very good for geese. They begin laying eggs at the proper time and do not stop early, as Tolna does not often experience extreme heat, which will make them stop laying eggs. Good, clean water, lots of summer grazing area, nice building in the winter to ‘hang out’ in, what more could a goose want?”

New BBC America Series “Survivors”


I watched this new BBC America Series about Survivors of a world wide flu epidemic. It is very good. It will be on Saturdays at 9:00 pm.

Set in the present day, Survivors focuses on the world in the aftermath of a virulent disease that scoured the planet, wiping out 99% of the human race. Only a lonely few are left to start over in a devastated world where everything that was once safe and familiar is now strange and dangerous.

A bewildered but resilient group of survivors is led by Abby Grant, a woman whose strength comes from a burning need to find out if her young son is still alive. Other members of the group include Greg (a good man who hides the pain of his past), Anya (a doctor who has seen too many people die) and Al, a former playboy who becomes surrogate father to streetwise urchin Najid. Then there is Tom, outwardly handsome and charming, but actually a dangerous and ruthless man who, unbeknown to the others, was a high-security prisoner before the virus hit.

This brave new world brings an opportunity for new beginnings, but also terrible dangers – not just the daily struggle for food and water, but also a deadly threat from other survivors.

“Survivors is about what it means to be human,” says award-winning writer and executive producer Adrian Hodges (co-creator and writer of Primeval). “It asks questions about our nature and confronts us with our deepest fears. When everything else is stripped away, would we band together and find the best in ourselves, or would we fall apart and retreat into barbarism and savagery?”

Hodges’ Survivors is a re-imagining of the classic ‘70s BBC drama series, and is based on the novel by Terry Nation. Hodges adds: “Survivors is about adventure, fear, love, loyalty and friendship. But above all, it’s about new hope.”

Survivors premieres Saturday, February 13, 8/7c – subsequent episodes premiere at 9/8c.

As H1N1 Slows Down, We will cover other food safety and health issues that can affect your family

U.S.D.A. unveils food safety initiatives
FoodBusinessNews.net, February 5, 2010
by Eric Schroeder

WASHINGTON — For the more than 31 million children who participate in the National School Lunch Program (N.S.L.P.), food safety help is on the way. Secretary of Agriculture Tom Vilsack on Feb. 4 announced several new initiatives to assure the safety and quality of food purchased by the U.S. Department of Agriculture for the N.S.L.P. and other food and nutrition assistance programs.

“Nothing is more important than the health and well-being of our nation’s school children,” Mr. Vilsack said. “We must do everything we can to ensure that our kids are being served safe, high quality foods at school. Today’s announcement demonstrates our commitment to constantly improving the safety and quality of foods purchased by U.S.D.A.”

As part of the effort, five U.S.D.A. agencies have set forth initiatives geared toward raising the food safety standards and testing protocols in schools to be more in line with that of restaurants and food retailers.

The initiatives include:

• The Agricultural Marketing Service (A.M.S.) said it will implement new food safety purchasing requirements for its beef suppliers as a result of a review of the beef purchase program conducted by the Food Safety and Inspection Service (F.S.I.S.) and the Agricultural Research Service (A.R.S.). The A.M.S. also said it will continue its zero tolerance for Salmonella and E. coli O157:H7 for its products and will continue to use onsite meat acceptance specialists and other control measures.

• The A.M.S. will look to the A.R.S. and the F.S.I.S. for technical assistance in regards to school lunch and other federal nutrition assistance programs. In addition, the A.M.S. said it has asked the National Academy of Sciences (N.A.S.) to review the ground beef purchasing program. By the summer, the N.A.S. is expected to have conducted a thorough evaluation of the scientific validity of the current A.M.S. technical requirements, with the review set to include benchmarking A.M.S. vendor requirements against recognized industry leading programs that supply product directly to consumers.

• The A.M.S. has vowed to increase information sharing with other agencies in order to better monitor vendor performance and identify potential food safety issues in the process. Included in the information sharing will be discussion on in-plant enforcement actions, positive pathogen test results, contract suspensions and recall notifications.

• The F.S.I.S. has agreed to work with the A.M.S. to review and evaluate meat, poultry, and processed egg vendors as part of the A.M.S. vendor eligibility process.

• The Food and Nutrition Service (F.N.S.) said it will review and evaluate methods currently being used by state agencies to communicate with schools and school districts regarding product recalls. The F.N.S. said it will develop performance criteria for states that allow them to provide rapid communication to schools and school districts, as well as provide financial assistance to states to allow them to upgrade the speed and accuracy of their food safety messages.

• The F.N.S. also has agreed to establish a Center of Excellence that will be devoted to research on school food safety issues in F.N.S. child nutrition programs. Research at the center is expected to include produce safety, proper cooling practices, evaluation of in-school food safety programs, and the containment of norovirus, according to the F.N.S.

• For its part, the Farm Service Agency (F.S.A.) has begun evaluating and strengthening current requirements and will amend those requirements to better reflect compliance with Good Manufacturing Practices and use of a verified Hazard Analysis and Critical Control Points program. The F.S.A. will ensure that commercial suppliers are able to provide a qualified level of food safety assurance for U.S.D.A. programs.

WHO slams swine flu critics as ‘irresponsible’

Commentary: Critics who say the Swine Flu Pandemic was overhyped arent looking at the facts. Tell the parents of the 300+ children who died that the pandemic was overblown. Using the logic of the critics, If your house in South Florida is Hurricane reinforced concrete and your neighbor built his from wood and his got destroyed and yours didn’t. Then you comment that the Hurricane wasnt that bad, and that it was overhyped. Bottom Line: Its not over yet and collectively we were lucky it wasn’t as virulent as thought because the government as usual botched the response and was slow to react. But to say the reaction by WHO was hyped is blatently wrong.

WHO slams swine flu critics as ‘irresponsible’
By Frank Jordans, Associated Press Writer , On Monday January 25, 2010, 8:23 am EST
GENEVA (AP) — The World Health Organization on Monday slammed as “irresponsible” critics who claim swine flu is a fake pandemic created for the benefit of drug companies.

The U.N. health agency said the outbreak of a new strain of H1N1 influenza in North America last year had all the scientific characteristics of a pandemic, adding the WHO was never improperly influenced by the pharmaceutical industry that has benefited from huge government orders for vaccines and anti-viral drugs.

“The world is going through a real pandemic. The description of it as a fake is wrong and irresponsible,” the WHO said in a strongly worded statement Monday.

A WHO spokesman declined to spell out who the World Health Organization was responding to in its statement, saying only that “this applies to anyone who believes it is not a real pandemic.”

The Parliamentary Assembly of the Council of Europe, a human rights watchdog based in Strasbourg, France, recently recommended that the EU investigate WHO’s swine flu pandemic declaration to see if the health agency acted under undue influence. WHO officials are due to meet Tuesday with the Council of Europe, which is not an official European Union body and has no power to act against WHO.

According to a WHO tally dated Jan. 17, more than 209 countries and territories have reported laboratory confirmed cases of swine flu, including at least 14,142 deaths. This is far fewer than would be expected to die each year from seasonal flu, but the figure is likely to exclude many unreported cases, according to WHO.

WHO spokesman Gregory Hartl said the relatively low number of confirmed deaths from swine flu didn’t mean the virus wasn’t a pandemic.

“A pandemic has nothing to do with severity or number of deaths,” he told The Associated Press. “A pandemic literally is a global spread of a disease.”

He said WHO was “always very measured and sober in what we said and we always described the virus as causing overwhelmingly mild disease. “We cannot control how people react to this information,” he added.

In its statement, WHO said it had put in place numerous safeguards to prevent conflicts of interest among its advisers, including requiring them to provide a signed declaration detailing any professional or financial interest that could affect their impartiality.

“WHO takes allegations of conflict of interest seriously and is confident of its decision-making independence regarding the pandemic influenza,” it said.

Swine Flu Vaccine Side Effects


I recieved a question from someone about having a reaction to a H1N1 flu shot. I advise the person to contact their Doctor but I have also posted some common reactions to the vaccine.

Swine Flu Vaccine Side Effects
Preliminary Safety of H1N1 Flu Shots Reported
Sep 19, 2009 Megan Doyle

Recently released reports detail common side effects experienced by recipients of the vaccines recently approved by the FDA for the prevention of the swine flu.

The FDA has approved four vaccines for the prevention of swine flu. Recent preliminary reports from clinical trials of these vaccines have described common side effects encountered by participants. The first of the preliminary reports published is from a continuing study in Australia, where researchers are testing an inactivated H1N1 vaccine developed by CSL Ltd. in a group 240 volunteers. Following injection, 90% of recipients achieved a strong immune response within three weeks, a sign that the vaccine is working. Participants reported side effects that they experienced within 7 days. Another study tested an H1N1 vaccine developed by Novartis Pharmaceuticals with and without an oil-in-water adjuvant, known as MF29 in 175 adults.

Local Side Effects from Approved H1N1 Vaccines
No deaths or serious adverse events have been reported from any swine flu vaccine. Approximately 44% of participants reported mild side effects within 7 days of receiving the first dose of CSL’s swine flu vaccine. 2.5% of vaccine recipients reported moderate local side effects, and there were no severe adverse events reported after immunization. 86% of the volunteers that received Novartis’s H1N1 vaccine reported adverse reactions after one or both doses – the most common local side effect experienced was injection site pain. The reactions were generally mild or moderate and resolved after 72 hours. Reported local adverse events, or side effects occurring at the location where either vaccine had been administered, include the following:

Tenderness
Pain
Redness
Hardening of skin
Swelling
Bruising
Common Systemic Side Effects from Swine Flu Vaccines
Systemic effects were also reported by CSL and Novartis vaccine recipients. Approximately 36% of volunteers that received the swine flu vaccine manufactured by CSL experienced mild systemic side effects. 8% of vaccine recipients reported moderate systemic side effects, and less than 1% experienced a severe adverse reaction to immunization. Severe side effects reported include, malaise, muscle pain, and nausea. Muscle aches were the most common systemic side effect reported by participants receiving the H1N1 vaccine produced by Novartis, and no severe systemic side effects were reported. The following are common whole-body side effects occurring in response to either H1N1 vaccination.

Headache
Malaise (feeling out-of-sorts)
Muscle pain
Chills
Nausea
Fever
Vomiting
In addition, researchers evaluated the occurrence of select adverse events including neurologic (e.g. Guillain-Barre syndrome), immune system or other serious reactions. According to the studies, none of the enrolled participants experienced these select events.

The National Institutes of Health (NIH) has also recently released preliminary safety information for an additional swine flu vaccine manufactured by Sanofi Pasteur Inc. Approximately 96% of healthy adults showed a robust immune response after receiving the vaccine. The only adverse events reported by trial participants were pain and redness at the injection site.

Read more at Suite101: Swine Flu Vaccine Side Effects: Preliminary Safety of H1N1 Flu Shots Reported http://diseases-viruses.suite101.com/article.cfm/swine_flu_vaccine_side_effects#ixzz0d5aCZD23

FDA Slams Tylenol Maker’s Delay in Tainted Pill Recall

FDA Slams Tylenol Maker’s Delay in Tainted Pill Recall
More Products, Including Tylenol Extra Strength and Rolaids, Recalled Due to Noxious Chemical Fears
By JOSEPH BROWNSTEIN
ABC News Medical Unit
Jan. 15, 2010—

The U.S. Food and Drug Administration slammed Tylenol manufacturer McNeil Healthcare LLC during a media briefing this morning for what it called a slow response to problems at a facility in Puerto Rico that led to consumers becoming sickened by tainted pills.

“McNeil should have acted faster,” said Deborah Autor, director of the FDA’s Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding “When something smells bad, literally or figuratively, companies must aggressively investigate” and take necessary action to solve the problem.

A recall of Tylenol products that began last month with the popular Tylenol arthritis caplet expanded this morning to include more than two dozen other over-the-counter products manufactured by McNeil.

The broadened directive adds 54 million bottles of product to the recall, boosting the total number of bottles recalled by McNeil to 60 million, according to the company.

McNeill initiated a voluntary recall of Tylenol Arthritis Relief Caplets at the end of December after consumer complaints of stomach problems. The problems were linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA), which results from the breakdown of a chemical in wood pallets used to transport and store packaging materials for the drugs.

Now it appears that the problem extended into other Tylenol products as well, according to the FDA.

Tylenol Extra Strength, Rolaids and a number of children’s medicines are now included in the recall, which affects 27 products in various packaging quantities.

McNeil released a statement today in which it said the voluntary recall is being conducted in consultation with the FDA and affects a number of products for which there have been no complaints.

The company added that the musty-smelling chemical thought to be the cause of the sickness posed no fatal risk to those who ingest it.

“The health effects of this chemical have not been well studied, but no serious events have been documented in the medical literature,” the statement read.

“In addition to the product recall, McNeil Consumer Healthcare is continuing its investigation into the issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets.”

In its statement, the company advised consumers who purchased the affected products to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.

Prior to today’s recall, the FDA had cited at least two of the company’s products in a letter to McNeil, as these products had been the subject of complaints about an “uncharacteristic smell,” similar to the one that helped trigger the recall of the arthritis caplets.

“Since the date of the discovery, your firm did not extend the assessment of the event to other products that received packaging components from the same supplier,” said the FDA’s letter, which was signed by Jose R. Lopez, an investigator, and Raquel Gonzalez Rivera, a chemist.

The letter goes on to cite over 10 “musty-moldy odor” complaints about Rolaids and over 39 similar complaints about Tylenol Extra Strength, “including three adverse event reports.”

The letter is dated Jan. 8, 2010, but was posted to the FDA’s Web site Jan. 13.

“Certainly, the FDA report raises serious questions about the manufacturer’s response,” said Robert Field, professor of health management and policy at the Drexel University School of Public Health. “The report has found that the investigation was limited…that the procedures for quality control were not in writing…and various other lapses that were fairly significant.”

The FDA report further criticized McNeil for inadequate responses to complaints, noting that they first received heightened complaints about the musty odor in 2008 and testing confirmed its presence in September of that year.

“Your quality unit failed to conduct additional testing to evaluate the possibility of chemical contamination or other change or deterioration in the distributed drug product,” the FDA letter says.

Karen Hirshfield, acting branch chief of the FDA Office of Compliance’s Recalls and Shortages Branch, revisted these concerns during this morning’s briefing.

“We would have expected McNeil to expand their investigation when they first learned of consumer complaints on this issue,” she said. “They became aware of a problem in September 2008, and their investigation and report to [the FDA] didn’t occur until about a year later. We would have expected action to occur sooner than that.”

Meanwhile, current problems with Rolaids and Tylenol Extra Strength are attributed to another testing failure.

“Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy,” the report said.

In response to an inquiry from ABC News correspondent David Kerley, the company responded on Thursday:

“McNeil Consumer Healthcare has received an FDA form 483 dated Jan. 8, 2010, and is actively working with the FDA to address their concerns.”

Effects of Tainted Pills Not Deadly
One positive for consumers is that, as ABC News Senior Medical Editor Dr. Richard Besser noted in December, after the first recall was announced, the effects of the tainted pills were not life threatening.

“They’re not that severe, we’re talking about vomiting, diarrhea,” said Besser. However, he advised, “if you have this product, you should get rid of them, safely dispose of them in your trash. You don’t want them around.”

Field agreed, following news of the initial recall.

“It does not look like there were serious health effects, if any,” he said, “but why take a chance? These products are supposed to improve your health, not hurt it.”

Most Americans somewhat confident in food safety- How about H1N1 Handling?

If the same poll were held and the question was, “How confident are you in the way the H1N1 Flu Virus was handled? How would you answer?

Poll: Most Americans somewhat confident in food safety

According to a CBS News poll of 1,048 American adults, only 32% say they are “very confident” about the safety of the food they buy, while 52% are “somewhat confident.” The remaining 16% say they are not too confident or not at all confident in the safety of their food.

These results are reflected in the grades Americans give the country on ensuring the safety of the food supply. The most commonly offered grade was C, chosen by 34% of those surveyed, and B, chosen by 33%. Just 7% gave the country an A when it comes to keeping the food supply safe. Meanwhile, 18% offered a D, and 6% served up a failing grade.

A person’s faith in the food supply may have something to do with the food they can afford. Those with high incomes are more confident in the safety of the food supply than those who earn comparatively less. Forty-two percent of Americans who make more than $100,000 are very confident the food they buy is safe, while just 24% of those who make less than $30,000 say the same.

Men are more likely than women to be very confident that the food they buy is safe, and college graduates are more likely than those with less education to say so. The region where Americans have the most trust in the food supply is the Midwest. Americans in the South have the least trust in the food supply.