Guillian barre syndrome is a frequent side effect of flu vaccination. One possible cause is that flu vaccine contains Campylobacter, said Dr Chen from the CDC. He said that the vaccine is made in chicken eggs and that 40-50% of chickens are infected with Campylobacter, which is difficult to eradicate.
http://www.cdc.gov/ncidod/dbmd/diseaseinfo/campylobacter_g.htm#
From the CDC's website
What is campylobacteriosis?
Campylobacteriosis is an infectious disease caused by bacteria of the genus Campylobacter. Most people who become ill with campylobacteriosis get diarrhea, cramping, abdominal pain, and fever within 2 to 5 days after exposure to the organism. The diarrhea may be bloody and can be accompanied by nausea and vomiting. The illness typically lasts 1 week. Some persons who are infected with Campylobacter don't have any symptoms at all. In persons with compromised immune systems, Campylobacter occasionally spreads to the bloodstream and causes a serious life-threatening infection.
How common is Campylobacter?
Campylobacter is one of the most common bacterial causes of diarrheal illness in the United States. Virtually all cases occur as isolated, sporadic events, not as a part of large outbreaks. Active surveillance through FoodNet indicates about 15 cases are diagnosed each year for each 100,000 persons in the population. Many more cases go undiagnosed or unreported, and campylobacteriosis is estimated to affect over 1 million persons every year, or 0.5% of the general population. Campylobacteriosis occurs much more frequently in the summer months than in the winter. The organism is isolated from infants and young adults more frequently than from other age groups and from males more frequently than females. Although Campylobacter doesn't commonly cause death, it has been estimated that approximately 100 persons with Campylobacter infections may die each year.
What sort of germ is Campylobacter?
The Campylobacter organism is actually a group of spiral-shaped bacteria that can cause disease in humans and animals. Most human illness is caused by one species, called Campylobacter jejuni, but 1% of human Campylobacter cases are caused by other species. Campylobacter jejuni grows best at the body temperature of a bird, and seems to be well adapted to birds, who carry it without becoming ill. The bacterium is fragile. It cannot tolerate drying and can be killed by oxygen. It grows only if there is less than the atmospheric amount of oxygen present. Freezing reduces the number of Campylobacter bacteria present on raw meat.
How is the infection diagnosed?
Many different kinds of infections can cause diarrhea and bloody diarrhea. Doctors can look for bacterial causes of diarrhea by asking a laboratory to culture a sample of stool from an ill person. Diagnosis of Campylobacter requires special laboratory culture procedures, which doctors may need to specifically request.
How can campylobacteriosis be treated?
Virtually all persons infected with Campylobacter will recover without any specific treatment. Patients should drink plenty of fluids as long as the diarrhea lasts. In more severe cases, antibiotics such as erythromycin or a fluoroquinolone can be used, and can shorten the duration of symptoms if they are given early in the illness. Your doctor will make the decision about whether antibiotics are necessary.
Are there long-term consequences?
Most people who get campylobacteriosis recover completely within 2 to 5 days, although sometimes recovery can take up to 10 days. Rarely, some long-term consequences can result from a Campylobacter infection. Some people may have arthritis following campylobacteriosis; others may develop a rare disease that affects the nerves of the body beginning several weeks after the diarrheal illness. This disease, called Guillain-Barré syndrome, occurs when a person's immune system is "triggered" to attack the body's own nerves, and can lead to paralysis that lasts several weeks and usually requires intensive care. It is estimated that approximately one in every 1000 reported campylobacteriosis cases leads to Guillain-Barré syndrome. As many as 40% of Guillain-Barré syndrome cases in this country may be triggered by campylobacteriosis.
How do people get infected with this germ?
Campylobacteriosis usually occurs in single, sporadic cases, but it can also occur in outbreaks, when a number of people become ill at one time. Most cases of campylobacteriosis are associated with handling raw poultry or eating raw or undercooked poultry meat. A very small number of Campylobacter organisms (fewer than 500) can cause illness in humans. Even one drop of juice from raw chicken meat can infect a person. One way to become infected is to cut poultry meat on a cutting board, and then use the unwashed cutting board or utensil to prepare vegetables or other raw or lightly cooked foods. The Campylobacter organisms from the raw meat can then spread to the other foods. The organism is not usually spread from person to person, but this can happen if the infected person is a small child or is producing a large volume of diarrhea. Larger outbreaks due to Campylobacter are not usually associated with raw poultry but are usually related to drinking unpasteurized milk or contaminated water. Animals can also be infected, and some people have acquired their infection from contact with the infected stool of an ill dog or cat.
How does food or water get contaminated with Campylobacter?
Many chicken flocks are silently infected with Campylobacter; that is, the chickens are infected with the organism but show no signs of illness. Campylobacter can be easily spread from bird to bird through a common water source or through contact with infected feces. When an infected bird is slaughtered, Campylobacter can be transferred from the intestines to the meat. More than half of the raw chicken in the United States market has Campylobacter on it. Campylobacter is also present in the giblets, especially the liver.
Unpasteurized milk can become contaminated if the cow has an infection with Campylobacter in her udder or the milk is contaminated with manure. Surface water and mountain streams can become contaminated from infected feces from cows or wild birds. This infection is common in the developing world, and travelers to foreign countries are also at risk for becoming infected with Campylobacter.
What can be done to prevent the infection?
There are some simple food handling practices for preventing Campylobacter infections. Physicians who diagnose campylobacteriosis and clinical laboratories that identify this organism should report their findings to the local health department. If many cases occur at the same time, it may mean that many people were exposed to a common contaminated food item or water source which might still be available to infect more people. When outbreaks occur, community education efforts can be directed at proper food handling techniques, especially thorough cooking of all poultry and other foods of animal origin, and common sense kitchen hygiene practices. Some data suggest that Campylobacter can spread through a chicken flock in their drinking water. Providing clean, chlorinated water sources for the chickens might prevent Campylobacter infections in poultry flocks and thereby decrease the amount of contaminated meat reaching the market place.
Some Tips for Preventing Campylobacteriosis
Cook all poultry products thoroughly. Make sure that the meat is cooked throughout (no longer pink), any juices run clear, and the inside is cooked to 170oF (77oC) for breast meat, and 180oF (82oC) for thigh meat.
If you are served undercooked poultry in a restaurant, send it back for further cooking.
Wash hands with soap before handling raw foods of animal origin. Wash hands with soap after handling raw foods of animal origin and before touching anything else.
Prevent cross-contamination in the kitchen:
Use separate cutting boards for foods of animal origin and other foods.
carefully clean all cutting boards, countertops and utensils with soap and hot water after preparing raw food of animal origin.
Avoid consuming unpasteurized milk and untreated surface water.
Make sure that persons with diarrhea, especially children, wash their hands carefully and frequently with soap to reduce the risk of spreading the infection. Wash hands with soap after having contact with pet feces.
My own addition to the list:
(DON'T GET A FLU SHOT!)
What are public health agencies doing to prevent or control campylobacteriosis?
To learn more about how Campylobacter causes disease and is spread, CDC began a national surveillance program in 1982. A more detailed active surveillance system was instituted in 1996; this will provide more information on how often this disease occurs and what the risk factors are for getting it. CDC is also making an effort to inform the public about campylobacteriosis and ways to avoid getting this disease. The U.S. Department of Agriculture conducts research on how to prevent the infection in chickens. The Food and Drug Administration has produced the Model Food Code, which could decrease the risk of contaminated chicken being served in commercial food establishments.
FDA Clearance to Conduct Proof of Principle/Field Trial of FluBlok(TM), its Cell-Culture Influenza Vaccine
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-28-2004/0002315456&EDATE=
Protein Sciences Announces FDA Clearance to Conduct Proof of Principle/Field Trial of FluBlok(TM), its Cell-Culture Influenza Vaccine
Enrollment of Subjects to Begin This Week at Three Sites MERIDEN, Conn., Oct. 28 /PRNewswire/ -- Protein Sciences Corporation, aworld leader in developing the next generation of human and veterinary vaccines, announced today that it had received FDA clearance to conduct a Phase II/III proof of principle/field study of FluBlok(TM), its patented cell culture influenza vaccine. The randomized, double blind, placebo controlled trial will be conducted in subjects aged 18-49 and will compare two different doses of FluBlok with a placebo group. The primary endpoints are to show safety and establish a commercial dose for FluBlok. A secondary endpoint is to establish efficacy under field conditions, which the study is powered to demonstrate with statistical significance if the influenza season is relatively robust. The study sites are the University of Rochester, NY (Dr.John Treanor, Study Principal Investigator), the University of Cincinnati Children's Hospital (Dr. Gilbert Schiff) and the University of Virginia (Dr.Frederick Hayden). Daniel D. Adams, President and CEO of Protein Sciences stated, "This is a very exciting time for us. Recent events highlight the critical need forinfluenza vaccines made using modern technology and cell culture. We believe that FluBlok is the only vaccine under development that can resolve all of the issues associated with the licensed egg-grown vaccines and therefore can address the entire potential market, estimated at more than $4 billion, for influenza vaccines. If this trial is successful, we plan to move immediately into a pivotal trial that we expect will lead to licensure. However, unfolding events may speed up the process. He added, "Recent events have highlighted our dependence on foreign companies for our influenza vaccines. We are, therefore, exceptionally well positioned because we are the only U.S. company with a cell culture influenza vaccine in late stage clinical trials, the only company conducting a late stage cell culture vaccine trial in the U.S. and the only company to have a potential pandemic vaccine tested in humans." FluBlok is like the licensed egg-grown vaccines because it contains antigens (hemagglutinin proteins) that are derived from three strains of the influenza virus that are selected for inclusion in the annual influenza vaccine by the CDC and the FDA. FluBlok presents a potential solution to the multitude of issues associated with the licensed vaccines that are grown in eggs. FluBlok's antigens are developed using recombinant DNA technology and manufactured in cell culture without eggs. Unlike the licensed vaccines and many cell culture vaccines in development, no live influenza viruses, bio containment facilities or harsh chemicals such as formaldehyde are used in manufacturing. FluBlok consists solely of three antigens (proteins) stored in sterile buffered salt water and without preservatives such as thimerosal, a mercury derivative currently used in egg-production, or adjuvants.
NewFluBlok vaccines can be developed quickly and safely to address late appearing influenza viruses such as A Fujian in 2003-2004 and emerging natural or man-made pandemic viruses, as evidenced by Protein Sciences' achievement in making a vaccine for the 1997-1998 Hong Kong "Bird" flu in just eight weeks. The 2004-2005 trial is being funded by the Company from its revenues, although the Company is raising additional capital through Credit Suisse First Boston to support future trials and commercial manufacturing. Seven previous clinical trials of FluBlok, all of which were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, showed safety and generation of antibody titers that are accepted as being protective against influenza. The latest trial was conducted in approximately 400 elderly subjects in 2003-2004 and compared a licensed egg-grown vaccine with three different doses of FluBlok containing the same hemagglutinin antigens.
The data showed that all doses of FluBlok were safe and achieved antibody levels that are believed to be associated with better protection against an H3 influenza virus(1) than subjects receiving the licensed vaccine. Historically, 30% to 50% of elderly subjects vaccinated with the licensed vaccines achieve protective titers against the H3 strain and, therefore, the goal was to show that at least 50% to 70% (20% more) of subjects vaccinated with FluBlok would achieve protective titers. Subjects receiving the highest doses of FluBlok exceeded the 20% goal -- 77% and 97%,respectively, of the subjects achieved protective titers as measured by Geometric Mean Titer, a common measure of vaccine effectiveness. Three additional studies over the next 12 months have been committed to by NIAID: one in B cell lymphoma patients that is underway; one using the Company's H5N1-- A Vietnam "bird flu" vaccine and a follow-on trial in the elderly that willinvolve revaccination and pre-vaccination stratification for antibody levels. About Protein Sciences. Founded in 1983, Protein Sciences is a vaccine company focused primarily on using modern technology to make the next generation of safer and more effective human and animal vaccines. The Company has a pipeline of patented products that includes two influenza vaccines that have completed Phase II(b) human clinical trials, one of which, FluBlok, has entered Phase II/III trials, and a SARS vaccine and erythropoietin that have completed animal tests and will enter human testing soon. All products are recombinant proteins that are made using the Company's patented protein expression technology, the baculovirus protein expression system (BEVS), in which it is the world leader. Protein Sciences also has service businesses that are driven by its BEVS technology including GeneXpress(R) (developing and manufacturing vaccines, therapeutics and diagnostics for customers) and manufacturing and selling proteins related to HIV/AIDS, SARS, influenza and pandemic influenza for research use. The Company has developed all of its products and businesses internally and retains commercial rights to its major products. Its facilities are located in Meriden, CT and include offices, research and development laboratories and a c GMP pilot plant capable of manufacturing clinical materials at the 600-Liter scale.
Website:http://www.proteinsciences.com. (1) The H3 strain causes the majority of the 20,000 to 70,000 excess influenza-related deaths each year in the U.S., more than 90% of which occur in the elderly. In the 2003-2004 influenza vaccine was A Panama and in the 2004-2005 vaccine was changed to A Wyoming.
SOURCE Protein Sciences Corporation
Web Site: http://www.proteinsciences.com
What's Bugging You?
The most common pathogenic organism found in raw milk is Staphyloccus aureus. Cows often get ulcers or sores on their udders. That bovine condition is known as mastitis, and the average cow in America requires $200 to treat that mastitis condition. Multiply that by 9.3 million dairy cows, and America's dairymen have a $2 billion yearly problem
I would like to recommend to you a remarkable book. "Killers Within" is the story of the deadly rise of drug-resistant bacteria. Written by Michael Schnayerson and Mark Plotkin, this book reads like a detective story. According to the authors:
Staphlococcus aureus is the most common infection of dairy cows. Bacterial toxins are easily passed from cows to humans in milk, and are not destroyed by pasteurization. On page 30, the authors write:
"Staph aureus bacteria are so virulent that very few are needed to do the job...it's the most successful of all bacterial pathogens and the number one cause of hospital infections in the world." I was fascinated to learn that many of the so-called miracle antibiotic drugs were derived from feces taken from sewers (page 35).
On page 123, the authors explain one reason that antibiotic use continues on many farms. Antibiotics are growth promoters. That explains why chickens, pigs, and cows are so overdosed. The authors go into great detail about new strains of bacteria that developed immunities to traditional antibiotics. Many Americans consume the antibiotic-resistant bacteria and become deathly ill. Some of these bacterial strains take residence in the human heart, and the ensuing disease in painfully expensive, painfully painful, and untreatable.
Cases of diarrhea from E. coli 157 or Guillain-Barre Syndrome from campylobacter can be traced to the diseased body fluids that we drink and infected flesh that we eat. The authors report a CDC study revealing that 60% of the 9.5 billions chickens sold in America each year are infected with campylobacter. Three out of every five chickens. If you eat chicken twice each week, thirty of your meals will come from highly toxic and infected flesh.
I was surprised to learn that 1.4 million Americans get salmonella each year, and 2-3% of those so infected get arthritis. I have not extended those numbers out over the course of a lifetime, but this information suggests a plague of bad health results from eating infected chickens. On page 173, the authors report that staph pneumo is the leading cause of acute otitis, or earaches in children. How many cases per year? About 6 million, according to the Centers for Disease Control. Earaches are the most common reason that children visit pediatricians, according to the authors.
Why are there new strains of bacteria?
The authors if "The Killers Within" do not explore the following:
In 1990, the Food and Drug Administration sent a message to dairy farmers: more drugs in milk was permissible. FDA arbitrarily increased the allowable level of antibiotics in milk by 100 times. The old protocol called for no more than one part per hundred million of antibiotic residues in milk. The change permitted antibiotic levels to be as high as one part per million. Consumers Union tested milk samples in the New York metropolitan area in 1992 and found the presence of 52 different antibiotics.
During that two-year period, cows were overdosed with antibiotics and new strains of bacteria developed. If an imaginary cow had one billion bacteria in her system and she was treated with streptomycin and that antibiotic killed all but one of those germs, that one survivor would be immune to the drug, then reproduce a new population with total immunity. Doubling its population every twenty minutes, it would take 10 hours for a new strain of bacteria to grow to one billion in number. Multiply that by 9 million cows and 52 different antibiotics, and it becomes clear to see why antibiotics no longer seem to work when they are needed.
Got Milk? Got Antibiotics!
The average American drinks milk and eats cheese containing new strains of bacteria, immune to the 52 different antibiotics which are also present in milk.
Children are dying, and scientists do not have a clue why.
Milk and dairy products should carry a warning label. Forty percent of the average American's diet consists of a product that is always infected with bacteria in its raw state. Raw milk usually contains blood, feces, bacterial and pus cells. Pasteurization does not kill all of the bacteria in milk. Many cheeses are not pasteurized. Rod-shaped bacteria form a spore (spore is the Greek word for seed) at the first sign of heat. When the milk cools, the spore "blooms" and the bacteria re-emerges into its toxic state.
Does pasteurization really work? On day ten you might pour out the offensive smelling milk in your refrigerator, and on day nine, you drink it.
Got Sick?
Robert Cohen
http://www.notmilk.com
http://www.cdc.gov/ncidod/dbmd/diseaseinfo/campylobacter_g.htm#
From the CDC's website
What is campylobacteriosis?
Campylobacteriosis is an infectious disease caused by bacteria of the genus Campylobacter. Most people who become ill with campylobacteriosis get diarrhea, cramping, abdominal pain, and fever within 2 to 5 days after exposure to the organism. The diarrhea may be bloody and can be accompanied by nausea and vomiting. The illness typically lasts 1 week. Some persons who are infected with Campylobacter don't have any symptoms at all. In persons with compromised immune systems, Campylobacter occasionally spreads to the bloodstream and causes a serious life-threatening infection.
How common is Campylobacter?
Campylobacter is one of the most common bacterial causes of diarrheal illness in the United States. Virtually all cases occur as isolated, sporadic events, not as a part of large outbreaks. Active surveillance through FoodNet indicates about 15 cases are diagnosed each year for each 100,000 persons in the population. Many more cases go undiagnosed or unreported, and campylobacteriosis is estimated to affect over 1 million persons every year, or 0.5% of the general population. Campylobacteriosis occurs much more frequently in the summer months than in the winter. The organism is isolated from infants and young adults more frequently than from other age groups and from males more frequently than females. Although Campylobacter doesn't commonly cause death, it has been estimated that approximately 100 persons with Campylobacter infections may die each year.
What sort of germ is Campylobacter?
The Campylobacter organism is actually a group of spiral-shaped bacteria that can cause disease in humans and animals. Most human illness is caused by one species, called Campylobacter jejuni, but 1% of human Campylobacter cases are caused by other species. Campylobacter jejuni grows best at the body temperature of a bird, and seems to be well adapted to birds, who carry it without becoming ill. The bacterium is fragile. It cannot tolerate drying and can be killed by oxygen. It grows only if there is less than the atmospheric amount of oxygen present. Freezing reduces the number of Campylobacter bacteria present on raw meat.
How is the infection diagnosed?
Many different kinds of infections can cause diarrhea and bloody diarrhea. Doctors can look for bacterial causes of diarrhea by asking a laboratory to culture a sample of stool from an ill person. Diagnosis of Campylobacter requires special laboratory culture procedures, which doctors may need to specifically request.
How can campylobacteriosis be treated?
Virtually all persons infected with Campylobacter will recover without any specific treatment. Patients should drink plenty of fluids as long as the diarrhea lasts. In more severe cases, antibiotics such as erythromycin or a fluoroquinolone can be used, and can shorten the duration of symptoms if they are given early in the illness. Your doctor will make the decision about whether antibiotics are necessary.
Are there long-term consequences?
Most people who get campylobacteriosis recover completely within 2 to 5 days, although sometimes recovery can take up to 10 days. Rarely, some long-term consequences can result from a Campylobacter infection. Some people may have arthritis following campylobacteriosis; others may develop a rare disease that affects the nerves of the body beginning several weeks after the diarrheal illness. This disease, called Guillain-Barré syndrome, occurs when a person's immune system is "triggered" to attack the body's own nerves, and can lead to paralysis that lasts several weeks and usually requires intensive care. It is estimated that approximately one in every 1000 reported campylobacteriosis cases leads to Guillain-Barré syndrome. As many as 40% of Guillain-Barré syndrome cases in this country may be triggered by campylobacteriosis.
How do people get infected with this germ?
Campylobacteriosis usually occurs in single, sporadic cases, but it can also occur in outbreaks, when a number of people become ill at one time. Most cases of campylobacteriosis are associated with handling raw poultry or eating raw or undercooked poultry meat. A very small number of Campylobacter organisms (fewer than 500) can cause illness in humans. Even one drop of juice from raw chicken meat can infect a person. One way to become infected is to cut poultry meat on a cutting board, and then use the unwashed cutting board or utensil to prepare vegetables or other raw or lightly cooked foods. The Campylobacter organisms from the raw meat can then spread to the other foods. The organism is not usually spread from person to person, but this can happen if the infected person is a small child or is producing a large volume of diarrhea. Larger outbreaks due to Campylobacter are not usually associated with raw poultry but are usually related to drinking unpasteurized milk or contaminated water. Animals can also be infected, and some people have acquired their infection from contact with the infected stool of an ill dog or cat.
How does food or water get contaminated with Campylobacter?
Many chicken flocks are silently infected with Campylobacter; that is, the chickens are infected with the organism but show no signs of illness. Campylobacter can be easily spread from bird to bird through a common water source or through contact with infected feces. When an infected bird is slaughtered, Campylobacter can be transferred from the intestines to the meat. More than half of the raw chicken in the United States market has Campylobacter on it. Campylobacter is also present in the giblets, especially the liver.
Unpasteurized milk can become contaminated if the cow has an infection with Campylobacter in her udder or the milk is contaminated with manure. Surface water and mountain streams can become contaminated from infected feces from cows or wild birds. This infection is common in the developing world, and travelers to foreign countries are also at risk for becoming infected with Campylobacter.
What can be done to prevent the infection?
There are some simple food handling practices for preventing Campylobacter infections. Physicians who diagnose campylobacteriosis and clinical laboratories that identify this organism should report their findings to the local health department. If many cases occur at the same time, it may mean that many people were exposed to a common contaminated food item or water source which might still be available to infect more people. When outbreaks occur, community education efforts can be directed at proper food handling techniques, especially thorough cooking of all poultry and other foods of animal origin, and common sense kitchen hygiene practices. Some data suggest that Campylobacter can spread through a chicken flock in their drinking water. Providing clean, chlorinated water sources for the chickens might prevent Campylobacter infections in poultry flocks and thereby decrease the amount of contaminated meat reaching the market place.
Some Tips for Preventing Campylobacteriosis
Cook all poultry products thoroughly. Make sure that the meat is cooked throughout (no longer pink), any juices run clear, and the inside is cooked to 170oF (77oC) for breast meat, and 180oF (82oC) for thigh meat.
If you are served undercooked poultry in a restaurant, send it back for further cooking.
Wash hands with soap before handling raw foods of animal origin. Wash hands with soap after handling raw foods of animal origin and before touching anything else.
Prevent cross-contamination in the kitchen:
Use separate cutting boards for foods of animal origin and other foods.
carefully clean all cutting boards, countertops and utensils with soap and hot water after preparing raw food of animal origin.
Avoid consuming unpasteurized milk and untreated surface water.
Make sure that persons with diarrhea, especially children, wash their hands carefully and frequently with soap to reduce the risk of spreading the infection. Wash hands with soap after having contact with pet feces.
My own addition to the list:
(DON'T GET A FLU SHOT!)
What are public health agencies doing to prevent or control campylobacteriosis?
To learn more about how Campylobacter causes disease and is spread, CDC began a national surveillance program in 1982. A more detailed active surveillance system was instituted in 1996; this will provide more information on how often this disease occurs and what the risk factors are for getting it. CDC is also making an effort to inform the public about campylobacteriosis and ways to avoid getting this disease. The U.S. Department of Agriculture conducts research on how to prevent the infection in chickens. The Food and Drug Administration has produced the Model Food Code, which could decrease the risk of contaminated chicken being served in commercial food establishments.
FDA Clearance to Conduct Proof of Principle/Field Trial of FluBlok(TM), its Cell-Culture Influenza Vaccine
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-28-2004/0002315456&EDATE=
Protein Sciences Announces FDA Clearance to Conduct Proof of Principle/Field Trial of FluBlok(TM), its Cell-Culture Influenza Vaccine
Enrollment of Subjects to Begin This Week at Three Sites MERIDEN, Conn., Oct. 28 /PRNewswire/ -- Protein Sciences Corporation, aworld leader in developing the next generation of human and veterinary vaccines, announced today that it had received FDA clearance to conduct a Phase II/III proof of principle/field study of FluBlok(TM), its patented cell culture influenza vaccine. The randomized, double blind, placebo controlled trial will be conducted in subjects aged 18-49 and will compare two different doses of FluBlok with a placebo group. The primary endpoints are to show safety and establish a commercial dose for FluBlok. A secondary endpoint is to establish efficacy under field conditions, which the study is powered to demonstrate with statistical significance if the influenza season is relatively robust. The study sites are the University of Rochester, NY (Dr.John Treanor, Study Principal Investigator), the University of Cincinnati Children's Hospital (Dr. Gilbert Schiff) and the University of Virginia (Dr.Frederick Hayden). Daniel D. Adams, President and CEO of Protein Sciences stated, "This is a very exciting time for us. Recent events highlight the critical need forinfluenza vaccines made using modern technology and cell culture. We believe that FluBlok is the only vaccine under development that can resolve all of the issues associated with the licensed egg-grown vaccines and therefore can address the entire potential market, estimated at more than $4 billion, for influenza vaccines. If this trial is successful, we plan to move immediately into a pivotal trial that we expect will lead to licensure. However, unfolding events may speed up the process. He added, "Recent events have highlighted our dependence on foreign companies for our influenza vaccines. We are, therefore, exceptionally well positioned because we are the only U.S. company with a cell culture influenza vaccine in late stage clinical trials, the only company conducting a late stage cell culture vaccine trial in the U.S. and the only company to have a potential pandemic vaccine tested in humans." FluBlok is like the licensed egg-grown vaccines because it contains antigens (hemagglutinin proteins) that are derived from three strains of the influenza virus that are selected for inclusion in the annual influenza vaccine by the CDC and the FDA. FluBlok presents a potential solution to the multitude of issues associated with the licensed vaccines that are grown in eggs. FluBlok's antigens are developed using recombinant DNA technology and manufactured in cell culture without eggs. Unlike the licensed vaccines and many cell culture vaccines in development, no live influenza viruses, bio containment facilities or harsh chemicals such as formaldehyde are used in manufacturing. FluBlok consists solely of three antigens (proteins) stored in sterile buffered salt water and without preservatives such as thimerosal, a mercury derivative currently used in egg-production, or adjuvants.
NewFluBlok vaccines can be developed quickly and safely to address late appearing influenza viruses such as A Fujian in 2003-2004 and emerging natural or man-made pandemic viruses, as evidenced by Protein Sciences' achievement in making a vaccine for the 1997-1998 Hong Kong "Bird" flu in just eight weeks. The 2004-2005 trial is being funded by the Company from its revenues, although the Company is raising additional capital through Credit Suisse First Boston to support future trials and commercial manufacturing. Seven previous clinical trials of FluBlok, all of which were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, showed safety and generation of antibody titers that are accepted as being protective against influenza. The latest trial was conducted in approximately 400 elderly subjects in 2003-2004 and compared a licensed egg-grown vaccine with three different doses of FluBlok containing the same hemagglutinin antigens.
The data showed that all doses of FluBlok were safe and achieved antibody levels that are believed to be associated with better protection against an H3 influenza virus(1) than subjects receiving the licensed vaccine. Historically, 30% to 50% of elderly subjects vaccinated with the licensed vaccines achieve protective titers against the H3 strain and, therefore, the goal was to show that at least 50% to 70% (20% more) of subjects vaccinated with FluBlok would achieve protective titers. Subjects receiving the highest doses of FluBlok exceeded the 20% goal -- 77% and 97%,respectively, of the subjects achieved protective titers as measured by Geometric Mean Titer, a common measure of vaccine effectiveness. Three additional studies over the next 12 months have been committed to by NIAID: one in B cell lymphoma patients that is underway; one using the Company's H5N1-- A Vietnam "bird flu" vaccine and a follow-on trial in the elderly that willinvolve revaccination and pre-vaccination stratification for antibody levels. About Protein Sciences. Founded in 1983, Protein Sciences is a vaccine company focused primarily on using modern technology to make the next generation of safer and more effective human and animal vaccines. The Company has a pipeline of patented products that includes two influenza vaccines that have completed Phase II(b) human clinical trials, one of which, FluBlok, has entered Phase II/III trials, and a SARS vaccine and erythropoietin that have completed animal tests and will enter human testing soon. All products are recombinant proteins that are made using the Company's patented protein expression technology, the baculovirus protein expression system (BEVS), in which it is the world leader. Protein Sciences also has service businesses that are driven by its BEVS technology including GeneXpress(R) (developing and manufacturing vaccines, therapeutics and diagnostics for customers) and manufacturing and selling proteins related to HIV/AIDS, SARS, influenza and pandemic influenza for research use. The Company has developed all of its products and businesses internally and retains commercial rights to its major products. Its facilities are located in Meriden, CT and include offices, research and development laboratories and a c GMP pilot plant capable of manufacturing clinical materials at the 600-Liter scale.
Website:http://www.proteinsciences.com. (1) The H3 strain causes the majority of the 20,000 to 70,000 excess influenza-related deaths each year in the U.S., more than 90% of which occur in the elderly. In the 2003-2004 influenza vaccine was A Panama and in the 2004-2005 vaccine was changed to A Wyoming.
SOURCE Protein Sciences Corporation
Web Site: http://www.proteinsciences.com
What's Bugging You?
The most common pathogenic organism found in raw milk is Staphyloccus aureus. Cows often get ulcers or sores on their udders. That bovine condition is known as mastitis, and the average cow in America requires $200 to treat that mastitis condition. Multiply that by 9.3 million dairy cows, and America's dairymen have a $2 billion yearly problem
I would like to recommend to you a remarkable book. "Killers Within" is the story of the deadly rise of drug-resistant bacteria. Written by Michael Schnayerson and Mark Plotkin, this book reads like a detective story. According to the authors:
Staphlococcus aureus is the most common infection of dairy cows. Bacterial toxins are easily passed from cows to humans in milk, and are not destroyed by pasteurization. On page 30, the authors write:
"Staph aureus bacteria are so virulent that very few are needed to do the job...it's the most successful of all bacterial pathogens and the number one cause of hospital infections in the world." I was fascinated to learn that many of the so-called miracle antibiotic drugs were derived from feces taken from sewers (page 35).
On page 123, the authors explain one reason that antibiotic use continues on many farms. Antibiotics are growth promoters. That explains why chickens, pigs, and cows are so overdosed. The authors go into great detail about new strains of bacteria that developed immunities to traditional antibiotics. Many Americans consume the antibiotic-resistant bacteria and become deathly ill. Some of these bacterial strains take residence in the human heart, and the ensuing disease in painfully expensive, painfully painful, and untreatable.
Cases of diarrhea from E. coli 157 or Guillain-Barre Syndrome from campylobacter can be traced to the diseased body fluids that we drink and infected flesh that we eat. The authors report a CDC study revealing that 60% of the 9.5 billions chickens sold in America each year are infected with campylobacter. Three out of every five chickens. If you eat chicken twice each week, thirty of your meals will come from highly toxic and infected flesh.
I was surprised to learn that 1.4 million Americans get salmonella each year, and 2-3% of those so infected get arthritis. I have not extended those numbers out over the course of a lifetime, but this information suggests a plague of bad health results from eating infected chickens. On page 173, the authors report that staph pneumo is the leading cause of acute otitis, or earaches in children. How many cases per year? About 6 million, according to the Centers for Disease Control. Earaches are the most common reason that children visit pediatricians, according to the authors.
Why are there new strains of bacteria?
The authors if "The Killers Within" do not explore the following:
In 1990, the Food and Drug Administration sent a message to dairy farmers: more drugs in milk was permissible. FDA arbitrarily increased the allowable level of antibiotics in milk by 100 times. The old protocol called for no more than one part per hundred million of antibiotic residues in milk. The change permitted antibiotic levels to be as high as one part per million. Consumers Union tested milk samples in the New York metropolitan area in 1992 and found the presence of 52 different antibiotics.
During that two-year period, cows were overdosed with antibiotics and new strains of bacteria developed. If an imaginary cow had one billion bacteria in her system and she was treated with streptomycin and that antibiotic killed all but one of those germs, that one survivor would be immune to the drug, then reproduce a new population with total immunity. Doubling its population every twenty minutes, it would take 10 hours for a new strain of bacteria to grow to one billion in number. Multiply that by 9 million cows and 52 different antibiotics, and it becomes clear to see why antibiotics no longer seem to work when they are needed.
Got Milk? Got Antibiotics!
The average American drinks milk and eats cheese containing new strains of bacteria, immune to the 52 different antibiotics which are also present in milk.
Children are dying, and scientists do not have a clue why.
Milk and dairy products should carry a warning label. Forty percent of the average American's diet consists of a product that is always infected with bacteria in its raw state. Raw milk usually contains blood, feces, bacterial and pus cells. Pasteurization does not kill all of the bacteria in milk. Many cheeses are not pasteurized. Rod-shaped bacteria form a spore (spore is the Greek word for seed) at the first sign of heat. When the milk cools, the spore "blooms" and the bacteria re-emerges into its toxic state.
Does pasteurization really work? On day ten you might pour out the offensive smelling milk in your refrigerator, and on day nine, you drink it.
Got Sick?
Robert Cohen
http://www.notmilk.com
