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MinorityView
12-01-10, 02:07 PM
I've got access to a database of newspaper articles through my library. I thought I'd share some of the Gardasil related ones here. The word Gardasil is highlighted because it was a search term.

More trouble with Gardasil - More young women and their parents are speaking out about problems with the human papillomavirus vaccine

Cape Cod Times (Hyannis, MA) - Thursday, December 3, 2009
Author: CYNTHIA McCORMICK



The list of local teens who believe they have experienced adverse reactions to the Gardasil vaccine has grown, with two sisters from Sandwich reporting medical problems following their shots.

Brianna Faiella, 15, developed aches, fever and swelling a few hours after receiving a dose of Gardasil and the seasonal flu nasal spray vaccine Aug. 25.

"By midnight, Brianna was barely breathing," says her mother, Mary Beth O'Brien. "Every joint and muscle in her body ached."

O'Brien drove her daughter to Newton-Wellesley Hospital, where Brianna's Needham-based pediatrician met them.

"There was nothing they could do for her other than to give pain medications and make her comfortable," O'Brien says. She says the pediatrician and hospital employees told her they were reporting the reaction to the Centers for Disease Control's Vaccine Adverse Event Reporting System (VAERS).

It was Brianna's first Gardasil shot. She's had the flu vaccine in the past with no ill effects, O'Brien says.

She says Brianna's older sister Annie also developed health problems following a Gardasil shot, but doctors are less sure of a possible connection to the vaccine developed to prevent some types of human papillomavirus.

Annie, a cheerleader and volleyball player at Sacred Heart Academy in Kingston, already had a complicated health history by the time she received her first Gardasil dose in April, O'Brien says.

Annie has a digestive disorder that also suppresses her immune system. A couple of weeks after her shot, she had to have her gall bladder removed. Several days after surgery she developed a severe rash.

"It ended up taking over her entire body. She looked like a burn victim with open wounds, bleeding," O'Brien says. "They put her on steroids. It didn't even touch this rash."

Annie had her second Gardasil shot later in the summer and currently takes cyclosporin to keep the rash down to an eczema-like simmer.

"When I get off the medicine, it full blooms," Annie says.

O'Brien wonders whether this is a severe form of the " Gardasil rash" reported by many young women.

She says she has cancelled the rest of the Gardasil series for Brianna, Annie and even Brianna's twin, Bethany, who suffered no ill effects from her first dose. A fourth daughter, her oldest, had all three shots without experiencing side effects.

A growing number of young women are joining the ranks of " Gardasil Girls," young women who believe they have been injured by the Merck vaccine that was approved in 2006 and has been heavily marketed as a preventive for cervical cancer.

On Oct. 15, the Cape Cod Times ran a story about three teens, all of whom developed a rash and other symptoms — in one case, partial paralysis — after their vaccinations.

One of O'Brien's neighbors, knowing she was frustrated about Annie's rash and Brianna's lingering health issues, showed her the article, O'Brien says.

Barbara Loe Fisher of the nonprofit National Vaccine Information Center says there are enough adverse reactions to the Gardasil vaccine to warrant a federal investigation.

Fisher, who is a founder of the vaccine watchdog group, has asked Congress and federal health agencies to look into VAERS reports that more than 3,000 young women have been harmed by the vaccine and 48 have died.

So far, the Centers for Disease Control and Prevention and the FDA say the vaccine — given in three separate shots — is safe and effective, with side effects including pain at the injection site, risk of fainting and blood clots.

A CDC vaccine report, last updated Nov. 5, says 26 million doses of Gardasil were distributed in the United States as of Sept. 1. The agency says that, based on its reporting systems, it continues to recommend Gardasil vaccination.

Cape pediatrician Leif Norenberg says he thinks Gardasil is a good vaccine. Patients' mothers have died of cervical cancer, he said, adding that HPV also can cause hysterectomies and repeat gynecological visits.

Patients falling ill after getting the vaccine doesn't mean there's a connection to Gardasil , Norenberg said. "Bad things happen to people without vaccines. I'm not real concerned about it."

But Nancy St. George of Pembroke is convinced Gardasil has destroyed the health of her 25-year-old daughter, Danielle St. George.

Danielle got her first shot in June 2007 and shortly afterward a lymph node on her collar bone swelled up, her mother said.

The swelling had subsided by the time of Danielle's second shot in August, but one week later her symptoms returned — with a vengeance.

"Every lymph node in her body was swollen," St. George said, adding that her daughter developed a rash, sweats and headaches.

Danielle suffered such severe muscle spasms that at times she couldn't walk, St. George said. One spasm was so severe her daughter broke her back molar and had to get a root canal and cap.

"She gets hives. Her eyes would get out of focus. Her voice would go," St. George says. Danielle, who was studying biology at the University of Massachusetts-Boston in the hope of becoming a doctor, now lives on Social Security disability.

St. George says the physician assistant who works for Danielle's doctor told the family she was reporting Danielle's case to VAERS, and the doctor said they'd never seen anything like this.

St. George wonders whether Danielle should even have been considered a candidate for Gardasil , given her medical history of a metal allergy and cat scratch fever.

"I think the third shot would have killed her," St. George says.

Fisher, of the vaccine watchdog group, says what Danielle may have experienced is a phenomenon known as "rechallenge."

In rechallenge cases, second and third doses of a vaccine cause symptoms to reappear or become worse, she says.

"It becomes very important when there are symptoms to not take them lightly and assume they are a coincidence," Fisher says. "It would be better to assume causation. That's the precautionary principle."

Swelling of the lymph nodes in particular indicates an inflammation in the body, she says. "It is not something to be ignored. Most doctors don't know how to treat it and stop the inflammation."

Looking back on her series of Gardasil shots, 18-year-old Nicole Goodman of Pocasset believes the migraine-type headaches she experienced after her first two doses were a tip-off something was wrong.

The Bourne High School graduate and former cheerleader and gymnast, who was profiled in the Oct. 15 article, experienced fainting episodes, nausea, low muscle tone, muscle spasms and partial paralysis of her left leg after her third dose.

Despite seeing a stream of specialists, her symptoms are getting worse, Goodman says. The dystonia — low muscle tone — has moved up her back, her eye muscles are affected and she is now on a catheter.

Fisher said it's "ridiculous" that federal officials are not taking Gardasil complaints seriously. Fisher says. She said 89 percent of reports on adverse reactions filed by Merck were incomplete.

"That's shocking," Fisher said.

Stories such as Danielle's, Brianna's, Annie's and Nicole's are a reason why the NVIC and some doctors are questioning the necessity of the Gardasil vaccine, which the CDC recommends for girls starting at age 11, Fisher says.

The HPV vaccine was developed to guard against four types of human papillomavirus, including two types that cause about 70 percent of cervical cancer.

Cervical cancer, while a major killer of women in developing countries, does not make the top 10 list of fatal malignancies for women in America, where routine screening with the Pap test drove cervical cancer deaths rates down 74 percent between 1955 to 1992.

In the Journal of the American Medical Association, Dr. Charlotte Haug of Norway editorialized that the cervical cancer cure and detection rate indicates a woman "should be willing to accept only a small risk of harmful effects from the vaccine."

In Sandwich, Brianna Faiella mainly has recovered from her vaccine scare.

"I'm doing a lot better," she says. "It took a while."

The three-sport athlete at Sacred Heart Academy now relies on an inhaler to get through her runs, and she seems permanently congested, said her mother.

And while her daughter Annie's cyclosporin treatments are helping to control her mystery rash, the treatments can't go on forever since they can lead to kidney damage, O'Brien says.

"Nobody can tell you what it is," she says. "We've seen so many specialists."

It's frustrating that there's no way to test whether the Gardasil or some kind of toxin caused her daughters' misery, O'Brien says.

"They just put you through so many tests and they all come back negative," Nancy St. George says. She says her daughter Danielle now has a diagnosis of fibromyalgia, but that doesn't tell half the story.

"There's no test for Gardasil syndrome," St. George says. "That's what I call it." Caption: Cape Cod Times/Ron Schloerb
gardasil shots Sisters Brianna, left, and Annie Faiella of Sandwich both have experienced possible negative side effects from Gardasil shots. Annie has developed a rash and Brianna bronchial problems.
Memo: The CDC's take

According to a "Vaccine Safety"

report issued this fall:

As of Sept. 1, more than 26 million doses of Gardasil vaccine had been distributed across the United States. As of Sept. 1, 15,037 VAERS reports of adverse effects had been filed, of which 93 percent were deemed non-serious. Seven percent were deemed serious.

The CDC uses three systems to monitor vaccine safety:

The Vaccine Adverse Event Reporting System (VAERS), based on reports sent in from physicians and clinics. The Vaccine Safety Datalink (VSD) Project, which studies patterns in VAERS reports. The Clinical Immunization Safety Assessment (CISA) Network, six academic centers that conduct research on adverse effects that might be caused by vaccines.

Source: www.cdc.gov/vaccinesafety/

MinorityView
12-01-10, 02:09 PM
an opinion post from a doctor:

Continued and expanded use of the HPV vaccine

Midland Daily News (MI) - Sunday, November 8, 2009


The news is the news. A female adolescent receives the human papillomavirus (HPV) vaccine, develops a blood clot, and it is immediately blamed on the vaccine.

I sometimes watch the evening news and just shake my head for the sheer disregard of even the simplest science. Three years after becoming available, and after 16 million injections, mothers still ask if the vaccine is safe for their teenage daughters. Most of these fears are based on news reports.

It is an appropriate question, though. Health professionals, too, have raised questions regarding safety of the HPV vaccine ( Gardasil ). The answer is now an unequivocal, "yes". It is safe.

The Center for Disease Control (CDC) and the Food and Drug Administration (FDA) are charged with approving, reviewing, and following vaccines to assure consumer safety. All concerns about vaccine safety are taken seriously. Gardasil does appear safe and effective.

The vaccine is indicated for females, 9 through 26. It is recommended as a general practice that girls receive the vaccine between 11 and 12 years of age. It is administered in three doses over six months. The purpose of the vaccine is to prevent diseases caused by the human papillomavirus (the wart virus). There are more than 100 different types of HPV. They are given numbers to identify them. HPV types 6 and 11 cause more than 90 percent of all genital warts. Types 16 and 18 account for 70 percent of cervical and vaginal cancers, as much as 50 percent of the vulvar cancers, and most of the penile cancers. Twelve thousand women are diagnosed with cervical cancer, and almost 4,000 die every year in the United States from this disease. Worldwide, it is the second most common cancer in women, causing an estimated half million new cases and a quarter million deaths per year. A vaccine that can prevent this from happening is certainly desirable. However, it must be safe.

Vaccines are manufactured in batches called lots. All lots are routinely tested and must pass all tests before they can be used. The FDA analyzes any possible side effects and looks for unusual patterns of disease in those who have been vaccinated. No such patterns have been observed in the FDA's review of HPV vaccine lots. The CDC works with eight managed care organizations that monitor vaccine safety. They also have a network of six academic centers in the United States to research any vaccine-associated events. To date, nothing significant has been found with the HPV vaccine.

Realize that if 16 million doses of Gardasil have been given in the last three years, some apparent complications will appear by chance alone. Even some deaths would normally occur for various reasons when this many people are given the vaccine. It just happens to be a random, coincidental occurrence -- the deaths and the vaccine are not related. Just because my dad washes his car and it rains doesn't mean he caused it to rain.

After the first two years of use, 9,714 adverse events were reported to the monitoring agencies. 94 percent were classified as non-serious events. This included fainting, pain at the injection site, headache, nausea, and fever. Six percent were classified as serious. Twenty deaths were reported shortly after receiving the Gardasil vaccine. There was no common pattern to these deaths . In all instances after review of the medical records, the cause of death was explained by factors other than the vaccine.

Guillain-Barre syndrome (GBS) was reported. GBS is a rare, neurological disorder causing muscle weakness. It can occur after any viral illness. No evidence was found that the vaccine increased the occurrence of GBS.

Blood clots were also reported. However, all the individuals had other risk factors to explain the clots, such as taking birth control pills. Blood clots are not associated with the vaccine.

The FDA and CDC in October of 2009, after their extensive reviews and monitoring, continue to recommend the HPV vaccine as safe and effective with benefits markedly outweighing the risks. There have been no safety issues identified in the purity or potency of Gardasil . The vaccine has already reduced abnormal Pap smears in recipients by 30-40 percent, and reduced operative procedures for abnormalities 20 percent.

As good as it is, the vaccine does not substitute for routine cervical cancer screening with Pap smears. It is not recommended for pregnant women. It may not result in protection for all recipients. It is not intended to be used for treatment of genital warts, cervical cancer, or other conditions but, rather, it is a preventative. It is best used prior to exposure to the HPV virus, which occurs during sexual contact. Even if a woman has an abnormal Pap smear or genital warts, she should still receive the vaccine because it is unlikely she has all four of the viruses the vaccine inhibits.

The latest news on the HPV vaccine includes the FDA recommendation that it be approved for males nine through 26 years of age. This is expected to receive overall endorsement soon. For males, it would prevent the majority of genital warts in the recipient, as well as prevent spread of all four viruses to his sexual partner. The other news is that a second product, Cervarix, was also approved. This vaccine is only effective against types 16 and 18, thus providing no protection against genital warts themselves.

Dr. John L. Pfenninger's column appears on Sundays. His office, Medical Procedures Center, is located in Midland.

MinorityView
12-01-10, 02:14 PM
Good news from australia?

Fewer genital warts thanks to HPV vaccine program

By ROBERT PREIDT

HealthDay

New cases of genital warts have declined sharply since vaccination of teen girls and young women against the human papillomavirus (HPV) began in Australia in 2007, a new study has found.

Certain types of HPV are linked with the development of cervical cancer.

Researchers analyzed data on new clients receiving treatment for genital warts at the Melbourne Sexual Health Center between 2004 and 2008. During that time, the center had 36,055 clients, and genital warts were diagnosed in 10.6 percent of cases. The number of women under age 28 who were newly diagnosed with genital warts decreased by 25 percent each quarter throughout 2008, the researchers found.

Australia began providing free vaccinations with Gardasil for females ages 12 to 26 in 2007. In the period before the vaccinations began, new cases of genital warts rose by nearly 2 percent each quarter, the study authors noted.

The study also found that newly diagnosed cases of genital warts among young men fell by an average of 5 percent each quarter throughout 2008. Rates of newly diagnosed genital warts among older women and men didn't decline.

The findings are published in the Oct. 15 online edition of the journal Sexually Transmitted Infections.

"The magnitude of the reduction in women [under] 28 years indicates a potential for substantial reductions in wart-associated morbidity and costs, and has important implications for countries deciding between the [ Gardasil and Cervarix] vaccine," the researchers wrote.

Gardasil protects against HPV types 6, 11, 16 and 18, while Cervarix protects against HPV types 16 and 18. Types 6 and 11 are associated with highly infectious genital warts, while types 16 and 18 are associated with cervical cancer.

On the Web

The U.S. Food and Drug Administration has more about HPV at http://www.fda.gov.

Momtezuma Tuatara
12-01-10, 02:54 PM
What's interesting in the last article is that nowhere is it mentioned as to how many of those people who had genital warts (GWs) had, or had not been vaccinated.

Why not?

neither was there any discussion as to what the long term trends have been in GWs.

there are so many medical article which talk about the rates at which all STD have been skyrocketting in the last few years, you would have thought that a big of "perspective" would be needed in order to see whether this trend is actually meaningful.

MinorityView
13-01-10, 12:33 AM
Yeah, I was wondering what the twist was on that one.

Generally, if a vaccine is suddenly related to a big benefit, there is some sort of twist, i.e. confounder, which isn't being discussed.

MinorityView
25-01-10, 01:06 AM
This one is from Canada, but close enough...

http://www.thestarphoenix.com/health/vaccine+remarkably+safe+despite+allergic+reactions/796891/story.html


New safety data is linking the cervical cancer vaccine with a significantly higher than expected rate of anaphylaxis, a severe allergic reaction that can be life-threatening.
But researchers caution the risk remains very low and shouldn’t curtail school-based vaccination programs being rolled out across Canada.
The study of 114,000 girls aged 12 to 26 vaccinated in Australia last year found an estimated rate of anaphylaxis of 2.6 per 100,000 doses of the human papillomavirus (HPV) vaccine - five- to 20-fold higher than rates reported for other vaccines. The rate of anaphylaxis in a 2003 school-based meningococcal vaccination program, by comparison, was 0.1 per 100,000 doses.
Note that they distort the risk for the individual by talking about the rate per 100,000 doses. With each girl receiving 3 doses, the reported rate is actually 2.6 per 33,000 girls. Sounds a bit worse, doesn't it?

And they compare it with a vaccine where one dose is given (I think), so the rate difference is really a lot worse than they are saying.

MinorityView
29-01-10, 03:19 AM
http://news10now.com/tompkins-cortland-news-1045-content/health/healthy_living/494416/is-the-hpv-vaccine-in-boys-really-worth-it-

the push to get the vaccine into boys:


01/27/2010 06:52 PM

Is the HPV Vaccine in Boys Really Worth it?


By: Casey J. Bortnick


http://images.news10now.com/media/2010/1/27/images/01hpvkids.jpg (http://images.news10now.com/media/2010/1/27/images/ENLARGE_01hpvkids.jpg)
The FDA approved a vaccine late last year to help prevent a common sexually transmitted disease in boys and young men.

Gardasil was approved for males ages 9 to 26 for the prevention of the human papillomavirus, or HPV. The vaccine is already being given to girls to prevent cervical cancer in women. But new research suggests including boys in these vaccination programs may not be cost-effective.

Like most young boys, Kyle Gleichauf seems more interested in video games then the opposite sex. But his mother is already thinking ahead.

"You have to think of it in the bigger spectrum," said Jennifer Gleichauf.

Years before he's sexually active Kyle’s mom is considering a vaccine that could protect him against a sexually transmitted disease.

"You're not just protecting your son. You're protecting your future daughter-in-law," Gleichauf added.

The human papillomavirus, or HPV, rarely causes cancer in boys, but experts says most parents would embrace the idea of getting their sons vaccinated anyway.

"Since most of the decisions about vaccines are made by mothers. I think they'll embrace the idea of having their sons take the vaccine and not transmit the virus to women," said Dr. Michael Pichichero of Rochester General Hospital.

There appears to be one major hurdle: cost.

"You're talking about $150 per vaccine. And you need three of them. That's a lot of money to invest," said Gleichauf.

Since some insurance companies won't pick up the tab, an HPV vaccine for both boys and girls may not be affordable.

"I do think a lot of people won't do it if it's not covered by insurance," Gleichauf said.

Despite the cost, Gleichauf will do everything she can to get Kyle vaccinated.

"It’s terrible that we're looking more at cost then preventing conditions," said Gleichauf.