FDA Expands HPV Vaccine Gardasil to Prevent Certain Cancers of the Vulva and Vagina
By Miranda Hitti
WebMD Health News
Reviewed by Louise Chang, MD
Sept. 12, 2008 -- The FDA today announced that the vaccine Gardasil may be used to prevent some cancers of the vulva and vagina in girls and women ages 9-26.
Gardasil is already approved to help prevent a leading cause of cervical cancer in women of that same age range.
Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.
"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.
"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman says.
Gardasil and HPV
Gardasil first gained FDA approval in 2006 for use in girls and women aged 9-26 to help prevent cervical cancer, precancerous genital lesions, and genital warts.
The CDC recommends Gardasil for all girls aged 11-12. Girls can get Gardasil when they're as young as 9. If they miss vaccination at ages 11-12, they can get vaccinated by age 26.
To be most effective, Gardasil should be given before a girl becomes sexually active. There are more than 100 strains of the HPV virus, and more than 30 of those strains can be spread through sex. According to the CDC, HPV is the most common sexually transmitted infection in the U.S, with some 6 million Americans becoming infected with genital HPV each year.
HPV doesn't always cause cervical cancer. For most women, the body's own defense system will clear HPV, preventing serious health problems. But some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.
Men can also carry HPV. But Gardasil isn't approved for use in men.
Gardasil vs. Vulvar, Vaginal Cancers
The FDA approved Gardasil to help prevent vulvar and vaginal cancers based on a follow-up report from Merck, the drug company that makes Gardasil, on more than 15,000 participants from Gardasil's original studies.
Merck followed those participants for two extra years and found that Gardasil was highly effective at preventing precancerous vulvar and vaginal growths related to HPV types 16 and 18, which the vaccine targets.
But Gardasil only showed that benefit in women who hadn't been infected with HPV before getting Gardasil.
"To receive Gardasil's full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine," states an FDA news release.
Gardasil's label has been revised to note that current information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil doesn't protect against diseases caused by HPV types not contained in the vaccine.
No vaccine is 100% effective, and Gardasil doesn't protect against HPV infections that a woman may already have at the time of vaccination. So the FDA recommends that all women get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.
The FDA notes that since Gardasil was approved, most reported adverse events haven't been serious. The most common reports have been of pain at the injection site, headache, nausea, and fever.
Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. The FDA recommends that observation period to watch for severe allergic reactions, which can occur after any immunization.
Wednesday, September 17, 2008
Wednesday, September 3, 2008
Needless vaccine can have deadly consequences
Dear Friend,
What will it take for Big Pharma to stop pushing their dangerous and useless vaccines? Apparently, one death a month is not going to be enough.
That's the rate at which women who have had Merck's cervical cancer vaccine, Gardasil, are dying, according to a new report. This is especially tragic because Gardasil is far and away the most unnecessary vaccine that's currently on the market (and that's really saying something).
An FDA report on Gardasil was recently obtained by Judicial Watch, a public interest group that campaigns against government corruption. They used the Freedom of Information act to show that the FDA has received reports of 10 deaths associated with Gardasil since September of 2007. Merck has come under fire for "fast-tracking" Gardasil to market without proper testing in order to be the first to offer this repulsive, needless vaccination.
In addition to the deaths, the report unearthed by Judicial Watch also noted a large number of other medical incidents involving Gardasil, including 140 serious adverse reactions (which included such pleasantries as anaphylactic shock, grand mal seizures, foaming at the mouth, coma, and paralysis – of these, 27 cases were considered life threatening), 10 spontaneous abortions, and six cases of Guillian-Barre Syndrome, a debilitating nerve disorder.
Sounds great, huh? But the above description is incredibly sanitized. The report found by Judicial Watch is a catalogue of horrors that includes the near instant death of many otherwise perfectly healthy women who died soon after their inoculation with Gardasil.
In one sickening case, a 14-year-old girl (who, I'll remind you, doesn't NEED a vaccination to avoid HPV), received her Gardasil shot, took six steps and then collapsed into unconsciousness, and began to foam at the mouth before coming out of it a minute later. Other patients weren't so lucky; one went into a coma and emerged paralyzed.
A 20-year-old with no medical history died four days after her Gardasil shot. Seven other women died within two days. And in one stunning instance, a woman died of a blood clot (the most common diagnosis in the case of the Gardasil-related deaths) within THREE HOURS of her inoculation.
In all, Judicial Watch says that at least 18 deaths are linked to the Gardasil vaccine, and it could be as many as 20.
All of these tragedies, and Merck has still had the nerve to put big bucks into getting every state in the country to MANDATE Gardasil to school girls as young as 11 years old. If it comes to that, believe me I'll be leading the revolution and storming the Capitol steps myself!
You can lay the blame for these horrors at the door of the idiots in the FDA, who allowed Merck's Big Pharma bucks to influence their decisions. As a result, they've turned all of America's young women into guinea pigs for their massive vaccine test.
"In the least, governments should rethink any efforts to mandate or promote this vaccine for children," said Tom Fitton, president of Judicial Watch. "Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and prohibit its distribution to minors."
Amen to that. But I'll go a step further: let's get the FDA to prohibit the use of Gardasil! It's a long shot since we don't have Big Pharma's money – but we can start by flooding those morons with letters! Who's with me!?
Guarding against the dangers of Gardasil,
William Campbell Douglass II, M.D.
What will it take for Big Pharma to stop pushing their dangerous and useless vaccines? Apparently, one death a month is not going to be enough.
That's the rate at which women who have had Merck's cervical cancer vaccine, Gardasil, are dying, according to a new report. This is especially tragic because Gardasil is far and away the most unnecessary vaccine that's currently on the market (and that's really saying something).
An FDA report on Gardasil was recently obtained by Judicial Watch, a public interest group that campaigns against government corruption. They used the Freedom of Information act to show that the FDA has received reports of 10 deaths associated with Gardasil since September of 2007. Merck has come under fire for "fast-tracking" Gardasil to market without proper testing in order to be the first to offer this repulsive, needless vaccination.
In addition to the deaths, the report unearthed by Judicial Watch also noted a large number of other medical incidents involving Gardasil, including 140 serious adverse reactions (which included such pleasantries as anaphylactic shock, grand mal seizures, foaming at the mouth, coma, and paralysis – of these, 27 cases were considered life threatening), 10 spontaneous abortions, and six cases of Guillian-Barre Syndrome, a debilitating nerve disorder.
Sounds great, huh? But the above description is incredibly sanitized. The report found by Judicial Watch is a catalogue of horrors that includes the near instant death of many otherwise perfectly healthy women who died soon after their inoculation with Gardasil.
In one sickening case, a 14-year-old girl (who, I'll remind you, doesn't NEED a vaccination to avoid HPV), received her Gardasil shot, took six steps and then collapsed into unconsciousness, and began to foam at the mouth before coming out of it a minute later. Other patients weren't so lucky; one went into a coma and emerged paralyzed.
A 20-year-old with no medical history died four days after her Gardasil shot. Seven other women died within two days. And in one stunning instance, a woman died of a blood clot (the most common diagnosis in the case of the Gardasil-related deaths) within THREE HOURS of her inoculation.
In all, Judicial Watch says that at least 18 deaths are linked to the Gardasil vaccine, and it could be as many as 20.
All of these tragedies, and Merck has still had the nerve to put big bucks into getting every state in the country to MANDATE Gardasil to school girls as young as 11 years old. If it comes to that, believe me I'll be leading the revolution and storming the Capitol steps myself!
You can lay the blame for these horrors at the door of the idiots in the FDA, who allowed Merck's Big Pharma bucks to influence their decisions. As a result, they've turned all of America's young women into guinea pigs for their massive vaccine test.
"In the least, governments should rethink any efforts to mandate or promote this vaccine for children," said Tom Fitton, president of Judicial Watch. "Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and prohibit its distribution to minors."
Amen to that. But I'll go a step further: let's get the FDA to prohibit the use of Gardasil! It's a long shot since we don't have Big Pharma's money – but we can start by flooding those morons with letters! Who's with me!?
Guarding against the dangers of Gardasil,
William Campbell Douglass II, M.D.
The truth about vaccine defenders
Dear Friend,
I've told you for years that many of the pro-vaccine crowd are hardly as unbiased and independent as they claim. I've long contended that many of these "independent" vaccination advocates are financially tied to Big Pharma and other pro-vaccine lobby groups. And now, finally, the mainstream media has started to follow the trail of pennies to the source of the vaccination issue. And guess what? Turns out I was right.
CBS News investigative correspondent Sharyl Attkinson discovered that some of the most prominent proponents of vaccination safety have "strong financial ties" to the Big Pharma companies that produce the vaccines they so vehemently defend.
In particular, CBS's Attkinson found significant financial connections between the American Academy of Pediatrics, Every Child By Two (an organization that promotes early childhood vaccination), and pediatrician Dr. Paul Offit.
Nobody seems to have paid much attention to my accusations over the years. Now that CBS News is on the case, maybe people will start to take notice. Then again, this kind of financial corruption and paid advocacy is so common these days (believe me, congressmen and senators are routinely courted by special interest lobbyists who make massive campaign contributions in order to influence votes), it's likely that people will just shake their heads in disgust and move on.
How bad are these financial ties? Judge for yourself:
The American Academy of Pediatrics received $342,000 from pharmaceutical giant Wyeth, producers of the vaccine pneumococcal (a product which generates a whopping $2 billion in annual sales for the company). And the year that the AAP endorsed Merck's HPV vaccine, they received a $433,000 "contribution" from Merck. Hmmm… do you think that "contribution" would have been as generous if the AAP had spoken out against the HPV vaccine?
Personally, these facts show another distasteful side to Big Pharma: they're as cheap as the day is long. The HPV vaccine makes $1.5 billion in sales, and all they gave for the AAP's "endorsement" is less than half a million bucks? Wonder if they said, "don't spend it all in one place?" I'm being facetious, of course; where there is one $433,000 payment, my guess is there are surely others.
As for Every Child By Two, they wouldn't even admit to the amount of contributions that they receive from Big Pharma, though they did admit that they do take money from the vaccine industry. A spokesman for Every Child By Two claimed that "there are simply no conflicts to be unearthed." Oh yeah? Then why is one of the group's treasurers an official from Wyeth Pharmaceutical?
But organizations are one thing; individuals quite another. And that's why to me the worst of the three on the Big Pharma payroll is Dr. Offit. This man has been quoted as saying that babies can tolerate – get this – "10,000 vaccines at once." Sickening, right? Well, Attkinson found that he also holds a Merck-funded $1.5 million research chair at the Children's Hospital of Philadelphia. Oh, and he also personally HOLDS THE PATENT on an anti-diarrhea vaccine that's produced by – who else? – Merck! The future royalties on this vaccine just sold for a staggering $182 million… no wonder Dr. Offit loves vaccines so much — he's apparently fully immunized himself against poverty.
Shining the light on Big Pharma's pro-vaccine roaches,
William Campbell Douglass II, M.D.
I've told you for years that many of the pro-vaccine crowd are hardly as unbiased and independent as they claim. I've long contended that many of these "independent" vaccination advocates are financially tied to Big Pharma and other pro-vaccine lobby groups. And now, finally, the mainstream media has started to follow the trail of pennies to the source of the vaccination issue. And guess what? Turns out I was right.
CBS News investigative correspondent Sharyl Attkinson discovered that some of the most prominent proponents of vaccination safety have "strong financial ties" to the Big Pharma companies that produce the vaccines they so vehemently defend.
In particular, CBS's Attkinson found significant financial connections between the American Academy of Pediatrics, Every Child By Two (an organization that promotes early childhood vaccination), and pediatrician Dr. Paul Offit.
Nobody seems to have paid much attention to my accusations over the years. Now that CBS News is on the case, maybe people will start to take notice. Then again, this kind of financial corruption and paid advocacy is so common these days (believe me, congressmen and senators are routinely courted by special interest lobbyists who make massive campaign contributions in order to influence votes), it's likely that people will just shake their heads in disgust and move on.
How bad are these financial ties? Judge for yourself:
The American Academy of Pediatrics received $342,000 from pharmaceutical giant Wyeth, producers of the vaccine pneumococcal (a product which generates a whopping $2 billion in annual sales for the company). And the year that the AAP endorsed Merck's HPV vaccine, they received a $433,000 "contribution" from Merck. Hmmm… do you think that "contribution" would have been as generous if the AAP had spoken out against the HPV vaccine?
Personally, these facts show another distasteful side to Big Pharma: they're as cheap as the day is long. The HPV vaccine makes $1.5 billion in sales, and all they gave for the AAP's "endorsement" is less than half a million bucks? Wonder if they said, "don't spend it all in one place?" I'm being facetious, of course; where there is one $433,000 payment, my guess is there are surely others.
As for Every Child By Two, they wouldn't even admit to the amount of contributions that they receive from Big Pharma, though they did admit that they do take money from the vaccine industry. A spokesman for Every Child By Two claimed that "there are simply no conflicts to be unearthed." Oh yeah? Then why is one of the group's treasurers an official from Wyeth Pharmaceutical?
But organizations are one thing; individuals quite another. And that's why to me the worst of the three on the Big Pharma payroll is Dr. Offit. This man has been quoted as saying that babies can tolerate – get this – "10,000 vaccines at once." Sickening, right? Well, Attkinson found that he also holds a Merck-funded $1.5 million research chair at the Children's Hospital of Philadelphia. Oh, and he also personally HOLDS THE PATENT on an anti-diarrhea vaccine that's produced by – who else? – Merck! The future royalties on this vaccine just sold for a staggering $182 million… no wonder Dr. Offit loves vaccines so much — he's apparently fully immunized himself against poverty.
Shining the light on Big Pharma's pro-vaccine roaches,
William Campbell Douglass II, M.D.
Gardasil linked to epilepsy
Dear Friend,
The anti-vaccination movement – as you know, one of my pet causes – has finally turned its sights on Gardasil, the human papilloma virus (HPV) vaccine manufactured by the pharmaceutical giant Merck. And it's about time.
Gardasil is marketed as a vaccine that combats cervical cancer, but the fact that it does so by guarding against a sexually transmitted disease is played down. After all, the only way to get HPV is by having sex. Yet Merck's commercials for Gardasil routinely depict girls as young as 11! Maybe it's just me, but I think it's better to step up as a parent and teach my daughter that sex is an adults-only activity, instead of just giving her a vaccine and hoping for the best.
But moral qualms aside, there now appear to be cases of negative reactions to the vaccine. A report in a recent edition of the Dallas Morning News told the tale of Katherine Kimzey, a 14-year-old girl who experienced headaches, fainting, and stiff joints after receiving the second shot of her three-dose Gardasil vaccine battery. A few weeks later, Katherine had a seizure and was eventually diagnosed with epilepsy. After reading VAERS (which stands for Vaccine Adverse Event Reporting System), a government database run by the CDC and the FDA that monitors vaccine safety, Katherine's mother was convinced that her daughter's troubles could be traced to the Gardasil shots she received.
"When you read everybody's stories, they're too similar not to be related," Michelle Kimzey said. The story of Katherine Kimzey has helped the anti-Gardasil movement gain a lot of momentum on the Web, especially in the anti-vaccine community.
If you look carefully, you might see Merck starting to break a sweat. After all, they've been pushing the Gardasil product worldwide to the tune of $1.5 billion in sales – a much-needed boon for the company after it was forced to withdraw its anti-arthritis drug Vioxx (which, you may recall, caused an increased risk of heart attacks). Of course, they're not going to go down without a fight. Dr. Jessica Kahn, a pediatrician and HPV researcher from Children's Hospital in Cincinnati pooh-poohed civilian misuse and misinterpretation of raw data on the VAERS system.
"It is very important to note that anyone can report a side effect to VAERS," Kahn said. "And just because it is reported it does not mean it was caused by a vaccine." Wouldn't you feel better if Dr. Kahn was looking for ways the vaccine might be linked to these terrible side effects, instead of trying to find ways that it's not? Thankfully, this hasn't stopped the cautionary tale of Katherine Kimzey from making its rounds on the Web and sounding the alarm about Gardasil.
So far, the CDC claims that they have not found a "causal link" between Gardasil and the serious side effects that are listed on VAERS. But they do admit that the fainting spell experienced by Katherine Kimzey is common. In fact, the Journal of the American Medical Association recently published a study of VAERS reports about Gardasil and fainting, which led to a recommendation that Gardasil recipients be kept seated or lying down for 15 minutes after receiving the shot.
Unfortunately, just taking 15 minutes off your feet will do nothing for the lifetime of epileptic seizures that could be caused by Gardasil. But I guess the CDC can't quite find that "causal link" yet… that is, if they're even looking for it. Giving the battle against vaccines a needed shot in the arm, William Campbell Douglass II, M.D. P.S. What do you think? Is the FDA taking the health risks of vaccines seriously enough?
Click here to participate in the Weekly Poll.
The anti-vaccination movement – as you know, one of my pet causes – has finally turned its sights on Gardasil, the human papilloma virus (HPV) vaccine manufactured by the pharmaceutical giant Merck. And it's about time.
Gardasil is marketed as a vaccine that combats cervical cancer, but the fact that it does so by guarding against a sexually transmitted disease is played down. After all, the only way to get HPV is by having sex. Yet Merck's commercials for Gardasil routinely depict girls as young as 11! Maybe it's just me, but I think it's better to step up as a parent and teach my daughter that sex is an adults-only activity, instead of just giving her a vaccine and hoping for the best.
But moral qualms aside, there now appear to be cases of negative reactions to the vaccine. A report in a recent edition of the Dallas Morning News told the tale of Katherine Kimzey, a 14-year-old girl who experienced headaches, fainting, and stiff joints after receiving the second shot of her three-dose Gardasil vaccine battery. A few weeks later, Katherine had a seizure and was eventually diagnosed with epilepsy. After reading VAERS (which stands for Vaccine Adverse Event Reporting System), a government database run by the CDC and the FDA that monitors vaccine safety, Katherine's mother was convinced that her daughter's troubles could be traced to the Gardasil shots she received.
"When you read everybody's stories, they're too similar not to be related," Michelle Kimzey said. The story of Katherine Kimzey has helped the anti-Gardasil movement gain a lot of momentum on the Web, especially in the anti-vaccine community.
If you look carefully, you might see Merck starting to break a sweat. After all, they've been pushing the Gardasil product worldwide to the tune of $1.5 billion in sales – a much-needed boon for the company after it was forced to withdraw its anti-arthritis drug Vioxx (which, you may recall, caused an increased risk of heart attacks). Of course, they're not going to go down without a fight. Dr. Jessica Kahn, a pediatrician and HPV researcher from Children's Hospital in Cincinnati pooh-poohed civilian misuse and misinterpretation of raw data on the VAERS system.
"It is very important to note that anyone can report a side effect to VAERS," Kahn said. "And just because it is reported it does not mean it was caused by a vaccine." Wouldn't you feel better if Dr. Kahn was looking for ways the vaccine might be linked to these terrible side effects, instead of trying to find ways that it's not? Thankfully, this hasn't stopped the cautionary tale of Katherine Kimzey from making its rounds on the Web and sounding the alarm about Gardasil.
So far, the CDC claims that they have not found a "causal link" between Gardasil and the serious side effects that are listed on VAERS. But they do admit that the fainting spell experienced by Katherine Kimzey is common. In fact, the Journal of the American Medical Association recently published a study of VAERS reports about Gardasil and fainting, which led to a recommendation that Gardasil recipients be kept seated or lying down for 15 minutes after receiving the shot.
Unfortunately, just taking 15 minutes off your feet will do nothing for the lifetime of epileptic seizures that could be caused by Gardasil. But I guess the CDC can't quite find that "causal link" yet… that is, if they're even looking for it. Giving the battle against vaccines a needed shot in the arm, William Campbell Douglass II, M.D. P.S. What do you think? Is the FDA taking the health risks of vaccines seriously enough?
Click here to participate in the Weekly Poll.
Hepatitis B Vaccine Linked to Onset of Diabetes
WebMD Health News
June 13, 2000 (San Antonio) -- Faced with an ever-growing list of required and recommended vaccinations for children -- as well as occasional reports of safety problems linked to vaccines -- many parents understandably feel confused. No doubt adding to that confusion are reports that the vaccine against hepatitis B, a blood-borne illness that can cause liver cancer, may actually lead to the development of type 1 diabetes in children.
Type 1 diabetes is the form where the body doesn?t make the insulin it needs. An Italian study presented here at the annual meeting of the American Diabetes Association suggests that children who get the hepatitis B vaccine are at greater risk for developing type 1 disease than those who have never been vaccinated. On the basis of their research, Paolo Pozzilli, MD, and colleagues say doctors should exercise caution in giving the vaccine to children who have close relatives with type 1 diabetes.
But because type 1 diabetes is relatively rare in the overall population, thorough studies involving several hundred thousand participants are needed to prove a solid link, says Marion Rewers, MD, who was not involved in the study. So the jury is still out, he says.
"The possibility of a link between hepatitis B vaccine [and type 1 diabetes] is an interesting research area and has been recognized as such by a number of investigators across the world," he tells WebMD. He says that at two recent meetings, researchers "were in unanimous agreement that there was no association. We need a monitoring system, so that if an association is found in the future, it can be promptly identified." Rewers, a pediatric endocrinologist, is a professor of pediatrics and preventive medicine at the University of Colorado in Denver and chair of the ADA council on epidemiology and statistics.
The CDC recommends that the hepatitis B vaccine be a part of routine vaccination schedules for U.S. infants.
The hepatitis B vaccine is now required in Italy, says Pozzilli, a professor of pediatrics at the University of Rome. Further, there is a low, relatively stable rate of type 1 diabetes there. These conditions allowed the researchers to compare the rate of diabetes in vaccinated children with that in unvaccinated groups.
Investigators compared 150,000 children who had been vaccinated at age 3 months to an equal number of unvaccinated children. To assess the risk of developing type 1 diabetes in children who got the vaccine later, after vaccination became mandatory in Italy, 400,000 children who were vaccinated at age 12 were compared with children who had not been vaccinated.
In the group as a whole, the rates of type 1 diabetes were 46 per 100,000 for children who had been vaccinated and 34 per 100,000 for children who had not. For those vaccinated at age 12, the rates were 17.8 per 100,000 for vaccinated children and 6.9 per 100,000 for unvaccinated children.
Although these may seem like large groups to study, they are not big enough for scientists to see clear patterns for type 1 diabetes, Rewers says. For a study like this to have value, the database should involve as many as 250,000 people in both the vaccinated and unvaccinated groups, he says.
"Caution is necessary when the potential of vaccine-related risks is studied," Rewers tells WebMD. "Without sound supportive data, [parents] can become unduly alarmed and stop immunizing their children." When immunization rates drop, diseases that can cause serious illness -- and death -- return, he tells WebMD.
The National Institutes of Health and the CDC are jointly establishing a system known as "sentinel monitoring areas," Rewers tells WebMD. The agencies will track the rate of type 1 diabetes in these areas -- consisting of selected counties in the U.S. -- and will determine whether the rate is related to things like immunizations, recommended infant feeding schedules, and outbreaks of infection.
Rewers has not been involved with the development of any vaccine and has no ties to any company that manufactures vaccines.
© 2000 WebMD, Inc. All rights reserved.
June 13, 2000 (San Antonio) -- Faced with an ever-growing list of required and recommended vaccinations for children -- as well as occasional reports of safety problems linked to vaccines -- many parents understandably feel confused. No doubt adding to that confusion are reports that the vaccine against hepatitis B, a blood-borne illness that can cause liver cancer, may actually lead to the development of type 1 diabetes in children.
Type 1 diabetes is the form where the body doesn?t make the insulin it needs. An Italian study presented here at the annual meeting of the American Diabetes Association suggests that children who get the hepatitis B vaccine are at greater risk for developing type 1 disease than those who have never been vaccinated. On the basis of their research, Paolo Pozzilli, MD, and colleagues say doctors should exercise caution in giving the vaccine to children who have close relatives with type 1 diabetes.
But because type 1 diabetes is relatively rare in the overall population, thorough studies involving several hundred thousand participants are needed to prove a solid link, says Marion Rewers, MD, who was not involved in the study. So the jury is still out, he says.
"The possibility of a link between hepatitis B vaccine [and type 1 diabetes] is an interesting research area and has been recognized as such by a number of investigators across the world," he tells WebMD. He says that at two recent meetings, researchers "were in unanimous agreement that there was no association. We need a monitoring system, so that if an association is found in the future, it can be promptly identified." Rewers, a pediatric endocrinologist, is a professor of pediatrics and preventive medicine at the University of Colorado in Denver and chair of the ADA council on epidemiology and statistics.
The CDC recommends that the hepatitis B vaccine be a part of routine vaccination schedules for U.S. infants.
The hepatitis B vaccine is now required in Italy, says Pozzilli, a professor of pediatrics at the University of Rome. Further, there is a low, relatively stable rate of type 1 diabetes there. These conditions allowed the researchers to compare the rate of diabetes in vaccinated children with that in unvaccinated groups.
Investigators compared 150,000 children who had been vaccinated at age 3 months to an equal number of unvaccinated children. To assess the risk of developing type 1 diabetes in children who got the vaccine later, after vaccination became mandatory in Italy, 400,000 children who were vaccinated at age 12 were compared with children who had not been vaccinated.
In the group as a whole, the rates of type 1 diabetes were 46 per 100,000 for children who had been vaccinated and 34 per 100,000 for children who had not. For those vaccinated at age 12, the rates were 17.8 per 100,000 for vaccinated children and 6.9 per 100,000 for unvaccinated children.
Although these may seem like large groups to study, they are not big enough for scientists to see clear patterns for type 1 diabetes, Rewers says. For a study like this to have value, the database should involve as many as 250,000 people in both the vaccinated and unvaccinated groups, he says.
"Caution is necessary when the potential of vaccine-related risks is studied," Rewers tells WebMD. "Without sound supportive data, [parents] can become unduly alarmed and stop immunizing their children." When immunization rates drop, diseases that can cause serious illness -- and death -- return, he tells WebMD.
The National Institutes of Health and the CDC are jointly establishing a system known as "sentinel monitoring areas," Rewers tells WebMD. The agencies will track the rate of type 1 diabetes in these areas -- consisting of selected counties in the U.S. -- and will determine whether the rate is related to things like immunizations, recommended infant feeding schedules, and outbreaks of infection.
Rewers has not been involved with the development of any vaccine and has no ties to any company that manufactures vaccines.
© 2000 WebMD, Inc. All rights reserved.
Hemophilus Meningitis Vaccine Linked To Diabetes Increase
BALTIMORE, MD -- May 7, 1999 -- The British Medical Journal published a Research Letter written by Dr. J. Bart Classen, an immunologist at Classen Immunotherapies, supporting a causal relationship between the hemophilus vaccine and the development of insulin dependent diabetes.
The data is particularly disturbing because it indicates the potential risks of the vaccine exceeds the potential benefit. The findings are expected to allow many diabetics to receive compensation for their injuries and lead to safer immunisation.
The data pertains to a study initiated and funded by Classen Immunotherapies which was performed using medical records of Finnish children. The study looked at the rate of diabetes in children receiving four or one dose of a weak, early generation, hemophilus vaccine and compared to the rate in children who received no vaccine. The children were followed for 10 years.
In the group receiving four doses of vaccine the rate of diabetes was elevated by 26 percent after seven years compared to children receiving no doses. There were an extra 58 cases of diabetes per 100,000 children immunised in the group receiving four doses of vaccine compared to children receiving no doses. This is equivalent to 2,300 cases of diabetes a year in the US, which has an annual birth rate of about four million children. However, even more cases of diabetes are expected with newer hemophilus vaccines which are in use today.
By contrast, immunisation against hemophilus is expected to prevent seven deaths and seven to 26 cases of severe disability per 100,000 children immunised in Finland.
The data shatters the prevailing myth that the benefits of vaccines far exceed the risks. The data is expected to allow many diabetic children to receive compensation for their illness. Each case of insulin dependent diabetes is estimated to cost on average over $1 million US in medical costs and lost productivity.
"Unfortunately, many public health officials and researchers funded by groups threatened by the findings continue to try to deny the association. This may prolong the financial burden of diabetics deserving compensation," Classen added.
In a letter published by the British Medical Journal, Classen describes analytical methods used by public health officials which may give readers the perception that the effect is smaller than it really is.
The news is not all bad for the vaccine field. The findings are expected to lead to changes in immunisation practices which will lead to a decline in childhood diabetes. Immunisation starting in the first month of life has been associated with a decreased risk of diabetes and is one method being considered to make immunisation safer.
Related Link: British Medical Journal
The data is particularly disturbing because it indicates the potential risks of the vaccine exceeds the potential benefit. The findings are expected to allow many diabetics to receive compensation for their injuries and lead to safer immunisation.
The data pertains to a study initiated and funded by Classen Immunotherapies which was performed using medical records of Finnish children. The study looked at the rate of diabetes in children receiving four or one dose of a weak, early generation, hemophilus vaccine and compared to the rate in children who received no vaccine. The children were followed for 10 years.
In the group receiving four doses of vaccine the rate of diabetes was elevated by 26 percent after seven years compared to children receiving no doses. There were an extra 58 cases of diabetes per 100,000 children immunised in the group receiving four doses of vaccine compared to children receiving no doses. This is equivalent to 2,300 cases of diabetes a year in the US, which has an annual birth rate of about four million children. However, even more cases of diabetes are expected with newer hemophilus vaccines which are in use today.
By contrast, immunisation against hemophilus is expected to prevent seven deaths and seven to 26 cases of severe disability per 100,000 children immunised in Finland.
The data shatters the prevailing myth that the benefits of vaccines far exceed the risks. The data is expected to allow many diabetic children to receive compensation for their illness. Each case of insulin dependent diabetes is estimated to cost on average over $1 million US in medical costs and lost productivity.
"Unfortunately, many public health officials and researchers funded by groups threatened by the findings continue to try to deny the association. This may prolong the financial burden of diabetics deserving compensation," Classen added.
In a letter published by the British Medical Journal, Classen describes analytical methods used by public health officials which may give readers the perception that the effect is smaller than it really is.
The news is not all bad for the vaccine field. The findings are expected to lead to changes in immunisation practices which will lead to a decline in childhood diabetes. Immunisation starting in the first month of life has been associated with a decreased risk of diabetes and is one method being considered to make immunisation safer.
Related Link: British Medical Journal
Vaccine Induced Inflammation Linked to Epidemic of Type 2 Diabetes and Metabolic...
Vaccine Induced Inflammation Linked to Epidemic of Type 2 Diabetes andMetabolic SyndromeJapanese and Other Ethnic Minorities at Increased Risk
BALTIMORE, April 4, 2008 /PRNewswire/ -- Newly published data by Dr. J.Barthelow Classen in The Open Endocrinology Journal shows a 50% reduction oftype 2 diabetes occurred in Japanese children following the discontinuation ofa single vaccine, a vaccine to prevent tuberculosis. This decline occurred ata time when there is a global epidemic of type 2 diabetes and metabolicsyndrome, which includes obesity, altered blood cholesterol levels, high bloodpressure, and increased blood glucose resulting from insulin resistance.
Classen proposes a new explanation for the epidemic of both insulindependent diabetes (type 1 diabetes), which has previously been shown to becaused by vaccines and non insulin dependent diabetes (type 2 diabetes). Uponreceipt of vaccines or other strong immune stimulants some individuals developa hyperactive immune system leading to autoimmune destruction of insulinsecreting cells. Other individuals produce increased cortisol, an immunesuppressing hormone, to suppress the vaccine induced inflammation. Theincreased cortisol leads to type 2 diabetes and metabolic syndrome. Japanesechildren have increased cortisol secretion following immunization compared toWhite children and this explains why Japanese have a relative high rate oftype 2 diabetes but low rate of insulin dependent diabetes compared to Whites.
The lower cortisol response attributed to type 1 diabetes and the highercortisol response attributed to type 2 diabetes explains why type 1 diabeticsare generally leaner than type 2 diabetics since elevated cortisol causesweight gain.
"The current data shows that vaccines are much more dangerous than thepublic is lead to believe and adequate testing has never been performed evenin healthy subjects to indicate that there is an overall improvement in healthfrom immunization. The current practice of vaccinating diabetics as well astheir close family members is a very risky practice," says Dr. J. Barthelow Classen.
Classen's research has become widely accepted. To view the publishedpapers and to find out the latest information on the effects of vaccines onautoimmune diseases including insulin dependent diabetes visit the VaccineSafety Web site www.vaccines.net/newpage11.htm
Classen Immunotherapies, Inc.
6517 Montrose Avenue
Baltimore, MD 21212 U.S.A.
Tel: (410) 377-8526
Classen@vaccines.net
vaccines.net
SOURCE Classen Immunotherapies, Inc.
Classen Immunotherapies, Inc., +1-410-377-8526, Classen@vaccines.net
BALTIMORE, April 4, 2008 /PRNewswire/ -- Newly published data by Dr. J.Barthelow Classen in The Open Endocrinology Journal shows a 50% reduction oftype 2 diabetes occurred in Japanese children following the discontinuation ofa single vaccine, a vaccine to prevent tuberculosis. This decline occurred ata time when there is a global epidemic of type 2 diabetes and metabolicsyndrome, which includes obesity, altered blood cholesterol levels, high bloodpressure, and increased blood glucose resulting from insulin resistance.
Classen proposes a new explanation for the epidemic of both insulindependent diabetes (type 1 diabetes), which has previously been shown to becaused by vaccines and non insulin dependent diabetes (type 2 diabetes). Uponreceipt of vaccines or other strong immune stimulants some individuals developa hyperactive immune system leading to autoimmune destruction of insulinsecreting cells. Other individuals produce increased cortisol, an immunesuppressing hormone, to suppress the vaccine induced inflammation. Theincreased cortisol leads to type 2 diabetes and metabolic syndrome. Japanesechildren have increased cortisol secretion following immunization compared toWhite children and this explains why Japanese have a relative high rate oftype 2 diabetes but low rate of insulin dependent diabetes compared to Whites.
The lower cortisol response attributed to type 1 diabetes and the highercortisol response attributed to type 2 diabetes explains why type 1 diabeticsare generally leaner than type 2 diabetics since elevated cortisol causesweight gain.
"The current data shows that vaccines are much more dangerous than thepublic is lead to believe and adequate testing has never been performed evenin healthy subjects to indicate that there is an overall improvement in healthfrom immunization. The current practice of vaccinating diabetics as well astheir close family members is a very risky practice," says Dr. J. Barthelow Classen.
Classen's research has become widely accepted. To view the publishedpapers and to find out the latest information on the effects of vaccines onautoimmune diseases including insulin dependent diabetes visit the VaccineSafety Web site www.vaccines.net/newpage11.htm
Classen Immunotherapies, Inc.
6517 Montrose Avenue
Baltimore, MD 21212 U.S.A.
Tel: (410) 377-8526
Classen@vaccines.net
vaccines.net
SOURCE Classen Immunotherapies, Inc.
Classen Immunotherapies, Inc., +1-410-377-8526, Classen@vaccines.net
Cancer Vaccine Linked to Pancreatitis
Sylvia Booth Hubbard
AOL Journals
September 2, 2008
Gardasil, the cervical cancer vaccine, which is being advised for all young women, may be causing pancreatitis, a painful, debilitating disease that can be fatal. Australian sources reported that three women developed pancreatitis shortly after receiving the vaccine.
Gardasil protects women from strains of the HPV (human papillomavirus) that cause 70 percent of all cervical cancer. But numerous cases of young women being stricken with various potentially deadly complications have arisen all over the world. Eighteen deaths have been reported as well as 8,000 adverse reactions which include paralysis and seizures. Australia alone reported over 1,000 suspected reactions to the vaccine, although most were not life-threatening and included headaches, dizziness and vomiting.
Acute pancreatitis is characterized by sudden, severe abdominal pain. Pancreatic enzymes burn and irritate the pancreas, then leak out into the abdominal cavity. Complications can include heart, respiratory or kidney failure, all of which can be fatal.
Dr. Amitabha Das, writing in the Medical Journal of Australia, said, “We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination.
AOL Journals
September 2, 2008
Gardasil, the cervical cancer vaccine, which is being advised for all young women, may be causing pancreatitis, a painful, debilitating disease that can be fatal. Australian sources reported that three women developed pancreatitis shortly after receiving the vaccine.
Gardasil protects women from strains of the HPV (human papillomavirus) that cause 70 percent of all cervical cancer. But numerous cases of young women being stricken with various potentially deadly complications have arisen all over the world. Eighteen deaths have been reported as well as 8,000 adverse reactions which include paralysis and seizures. Australia alone reported over 1,000 suspected reactions to the vaccine, although most were not life-threatening and included headaches, dizziness and vomiting.
Acute pancreatitis is characterized by sudden, severe abdominal pain. Pancreatic enzymes burn and irritate the pancreas, then leak out into the abdominal cavity. Complications can include heart, respiratory or kidney failure, all of which can be fatal.
Dr. Amitabha Das, writing in the Medical Journal of Australia, said, “We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination.
Subscribe to:
Posts (Atom)