(Photo is the gravestone of Miss Jessica Erickson who died following Gardasil vaccination. Her story "Guinea Pig" is one of the media articles mentioned below. We've been in contact with her family in the past, her Mom is a warrior in the name of her child. And we show her gravestone not be macabre, but as a stark reminder that HPV vaccination is not without risk.)
By J.B. Handley
We all know that AoA is no place to discuss our politics. The parents reading this blog are unified in their commitment to one issue, and that’s autism.
At this point, I’m nearly a single-issue voter, and Michelle Bachmann has certainly done our community a huge favor by publicly discussing the well-known risks from receiving the Gardasil vaccine. Taken from a post back in December 2009, here are just a few of the hundreds of headlines out there about Gardasil:
October 29, 2007, UK Telegraph: Cervical cancer drug Gardasil linked to deaths Fears have been raised over the safety of a cervical cancer vaccine which health officials plan to give all 12-year-old girls, after it was revealed that the drug has been linked to several deaths. Three young women are reported to have died days after the drug Gardasil was administered, while the jab is also suspected of triggering "adverse reactions" in 1,700 patients. The figures were uncovered by campaigners who made a freedom of information request in the US, where the vaccine was approved for use a year ago…
January 25, 2008, UK Daily Mail:
A jab that could be given to hundreds of thousands of schoolgirls this autumn was at the centre at a safety scare last night following the deaths of two young women…
February 6, 2008, East Bay Express:
In early 2007, as the pharmaceutical giant Merck began promoting its new vaccine Gardasil as protection against cervical cancer, Brooke Petkevicius was a nineteen-year-old freshman at UC Berkeley. She had seen the ads for the vaccine, and discussed getting it with her mother, whose gynecologist also had recommended it. On March 12, Brooke received the first of three doses. Two weeks later, she dressed to go running with a friend. As they reached the elevator, Brooke suddenly collapsed against the wall and had a seizure.
June 30, 2008, WorldNet Daily
"Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” said Judicial Watch President Tom Fitton. The organization's work uncovered reports of about one death each month since last fall, bringing the total death toll from the drug to at least 18 and as many as 20. There also were 140 "serious" reports of complications including about three dozen classified as life-threatening, 10 spontaneous abortions and half a dozen cases of Guillain-Barre Syndrome.
July 20, 2008, New York Post:
Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.
Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006…Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen…Lisa Ericzon now feels her daughter was "a guinea pig" for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.
"I want other mothers to know," said Lisa, the first parent of a girl who died after Gardasil to speak publicly.
July 26, 2008, Medscape:
Serious neurologic, thromboembolic, and autoimmune complications have been reported in patients who received human papillomavirus (HPV) vaccines. Although not the norm, experts suggest that the events are grave enough to encourage caution. "The side effects that have been reported are real and they cannot be brushed aside," Diane Harper, MD, from the Dartmouth Medical School, in Hanover, New Hampshire, told Medscape Oncology. Dr. Harper was a principal investigator of clinical HPV vaccine trials for both Merck and GlaxoSmithKline…
August 17, 2008, Canberra Times (Australia):
The cervical cancer vaccine is under fresh scrutiny after three women were struck down with pancreatitis soon after receiving the injection.
February 6, 2009, CBS Evening News:
Gabby Swank was a straight-A student and cheerleader. But that was before she became very ill following the standard dose of three Gardasil vaccinations, Attkisson reports. "It was like a big hype among my friends, because we're like, 'we're gonna get it' because we felt almost pressured by the commercials," Gabby said. Gabby got sicker after each shot, progressing to seizures, strokes and heart problems. It was her neurologist who suspected Gardasil was to blame. "I think there are too many people having serious long-term side-effects," said neurologist Dr. Dwight Lindholm.
February 13, 2009, Agence France-Presse:
MADRID (AFP) — Spanish health authorities have withdrawn tens of thousands of doses of a vaccine against cervical cancer after two teenagers who received the shots were hospitalised, regional authorities said on Tuesday…
August 18, 2009, WCBV-TV Boston (ABC):
Adverse Events Linked To HPV Vaccine Adverse Events Linked To HPV Vaccine
“When it came on the market more than three years ago, Gardasil was widely touted and marketed as the first vaccine that might prevent cancer. …Now the Journal of the American Medical Association has published a compilation of the more than 10,000 complaints reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) since June 2006 when Gardasil was granted FDA approval…VAERS records show that there was an average of 53.9 reports per 100,000 vaccine doses distributed. Six percent were serious, including 32 deaths. Merck, the company that makes Gardasil, stands by its safety and effectiveness.”
August 19, 2009
October 9, 2009, UK Daily Mail:
“An NHS trust today suspended all cervical cancer vaccinations after a 14-year-old girl died hours after being given the vaccine…”
October 15, 2009, Kansas Liberty:
Shannon Schrag, a Wichita mother who says her teen now suffers from a terminal illness due to receiving the Gardasil vaccination, spoke at the conference, which was held in Washington, D.C. Schrag’s daughter, Gabi Swank, 16, was diagnosed with central nervous system vasculitis and central nervous system lupus after receiving the third Gardasil injection. Gabi’s neurologist, Dr. Dwight Lindholm, has publicly stated that he believes Gabi’s illness is the direct result of receiving the Gardasil injections.
October 16, 2009, WebMD Health News:
“Researchers believe that there may be a link between a vaccine against cervical cancer and a rapidly progressive, fatal disease in two young women.”
October 17, 2009, Cape Cod Times:
“It's been months since dancer and former gymnast Nicole Goodman of Pocasset has been able to do a forward jazz slide or a kick ball change move…The 18-year-old fell ill weeks after receiving her third Gardasil shot, and she blames the vaccine for the human papillomavirus for putting her in a wheelchair.”
* * *
If all those reports aren’t to make any vaccine-trusting parent worried, than certainly the words of Diane Harper are, from CBS News:
Gardasil Researcher Speaks Out
By Sharyl Attkisson
(CBS) Amid questions about the safety of the HPV vaccine Gardasil one o the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It's highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.
Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine's risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.
This raises questions about the CDC's recommendation that the series of shots be given to girls as young as 11-years old. "If we vaccinate 11 year olds and the protection doesn't last... we've put them at harm from side effects, small but real, for no benefit," says Dr. Harper. "The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated." She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.
Dr. Scott Ratner and his wife, who's also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she'd have been better off getting cervical cancer than the vaccination. "My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I've had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways."
Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil's safety profile. Merck also says it's looking into cases of ALS, commonly known as Lou Gehrig's Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it's unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn't mean the shots were necessarily to blame.
According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program."
"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC's Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from Merck's warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information," said Harper.
Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks - "small but real" - could occur more often than the cervical cancer itself would.
"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade's work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil."
She also worries that Merck's aggressive marketing of the vaccine may have given women a false sense of security. "The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers - something never stated, but often inferred by many in the population-- a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably."
CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine's benefits outweigh its risks and that it is an important tool in fighting a serious cancer.
Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. "Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil."