A wonder drug’s dark side
Hundreds of thousands of teen girls in Canada have safely taken Gardasil, a vaccine shown to prevent HPV. But a Star investigation has found that since 2008, at least 60 Canadians experienced debilitating illnesses after inoculation. Patients and parents say the incidents point to the importance of full disclosure of risks
By the time Kaitlyn Armstrong received her third and final injection of the popular HPV vaccine Gardasil, pain had spread through the Whitby teen’s body, migrating from her back to her knees to her hips.
After her first dose, Natalie Kenzie of London developed egg-size lumps on the soles of her feet, her joints swelled and her limbs twitched uncontrollably.
Before getting the shots, both 13-year-old girls were told the vaccine had no significant risks. And as they struggled to learn what ailed them, and began to believe Gardasil played a role, doctors dismissed their concerns.
Hundreds of thousands of teenage girls in Canada have received the vaccine’s three doses, the vast majority without incident.
Regulators, including Health Canada and the FDA in the United States, cite comprehensive clinical trials and other data that show the vaccine’s well-studied safety and efficacy.
But since 2008 at least 60 girls and women in Canada have convulsed or developed disabling joint and muscle pain and other debilitating conditions after receiving Gardasil.
One needed a wheelchair, another a feeding tube. A 14-year-old Quebec girl, Annabelle Morin, died two weeks after receiving the second injection of the vaccine.
It was 7:30 p.m. on the night of Dec. 9, 2008, when her mother, Linda, found her in the tub, her head underwater and turned to the side.
The paramedics lifted Annabelle’s body on to a stretcher. “I put a blanket on her, saying, ‘She’s going to freeze,’ ” Linda recalled. “I did not know she was already dead.”
The Quebec coroner’s office said the cause of death was drowning, yet also said that any role Gardasil might have played should be further investigated.
In the cases discussed in this article, it is the opinion of a patient or doctor that a particular drug has caused a side-effect.
There is no conclusive evidence showing the vaccine caused a death or illness.
Like Kenzie and Armstrong, many of the girls say the vaccine was pushed on them by school officials, nurses or doctors who understated the risks, sometimes claiming zero significant side effects despite the existence of a list of rare but serious vaccine-related reactions published by the drug’s maker.
The Star has found the girls’ concerns are not isolated, that in Canada important safety information about the vaccine has not been communicated to many young patients and their parents.
As part of its ongoing investigation into drug safety, the newspaper analyzed sideeffect reports from a Health Canada data- base, and interviewed regulators, a doctor closely involved in the vaccine’s clinical trial and, in 12 cases, young women and parents who believe the vaccine caused considerable suffering.
Some of the girls have, after several years, made partial recoveries and are trying to live normal lives. Others are still bouncing from doctor to doctor, looking for answers.
Approved in more than 130 countries, the vaccine protects against strains of human papillomavirus (HPV) that cause 70 per cent of cervical cancer cases and 90 per cent of genital warts. Roughly 400 Canadian women die of cervical cancer each year.
HPV is a common sexually transmitted infection. By targeting girls in their young teens, health officials seek to vaccinate them before they become sexually active. The vaccine is ineffective for someone already infected with these strains.
While Health Canada and the U.S. FDA say the vaccine is safe, officials in other countries have sounded alarms. In 2013, Japan’s health ministry said it would stop promoting the vaccine while it looked into serious side-effect reports.
Gardasil was approved in the U.S. in 2006, and Health Canada soon followed by issuing Merck a licence to sell the vaccine north of the border.
Leading health authorities have largely lauded Gardasil, a series of shots that cost a total of $400-$500 and that, in Canada, provinces pay for and public health nurses administer in schools. The three shots are given over six months.
Merck-sponsored trials found the vaccine prevented nearly100 per cent of abnormal growths — precursors to cervical cancer — related to two HPV types. Trials also found serious side-effects were rare, with just five reactions among more than 11,000 Gardasil recipients that were found to be possibly, probably or definitely related to the injection.
“I’m extremely comfortable that this is a safe vaccine,” said Dr. Jennifer Blake, president of the Society of Obstetricians and Gynaecologists of Canada.
There was an intense lobbying effort behind Gardasil’s rollout in 2007.
Eight months after being approved for sale, a national vaccination program was born. Ottawa committed $300 million. In Ontario, officials announced that all Grade 8 girls would have free access to Gardasil.
Critics were wary of the quick embrace of Gardasil, saying the vaccine’s long-term efficacy and risk were unknown.
Kaitlyn Armstrong said she and her fellow eighth graders heard about Gardasil from a guidance counsellor during a short information session given at her Whitby school in September or October of 2009.
“She told us it was going to protect us from cervical cancer, it’s a really good idea to get it. She was pushing it. She didn’t talk about any complications or any of that stuff,” recalled Armstrong, who is now 17 and wants to be a pediatric nurse. “My grandpa had died a few months before from cancer, so of course I was right on board.”
At the time, Armstrong danced 20 hours a week, played soccer and ran track. After the first Gardasil shot, the pain started in her back. After the second and third shot, it spread to other joints, her knees and hips. Amanda Dubreuil, who taught Kaitlyn at her Oshawa dance studio, remembers what happened next.
“It was one of the saddest things I’ve ever seen. When I first started teaching her, she was so incredibly strong, one of the most physically gifted girls I had seen in a while. Over the course of three months she started deteriorating.”
Before each of the three shots, a public health nurse asked Kaitlyn if she had any allergies. Each time, Kaitlyn said, she responded, “Yes, I am allergic to metal,” and the nurses said nothing in response and then gave the shot. (Since Kaitlyn was a baby, metal, such as the snaps on an infant’s onesie, would cause rashes on her skin, she and her mother said.) Kaitlyn says neither the school nor the nurses told her that one of the ingredients of the vaccine is aluminum salts.
There were numerous visits to doctors, she had MRIs and other tests, and was given painkillers. Eventually a doctor diagnosed her with fibromyalgia, a pain disorder.
Citing patient privacy, a Durham Region public health official said she could not discuss specific cases, but said Durham’s vaccination program educates students about the benefits and risks, including allergies.
Merck, the company that makes Gardasil, did not comment on Armstrong’s case but said “if a patient has a hypersensitivity to any ingredient . . . then Gardasil would be contraindicated for that patient.”
A recent analysis by several Canadian health-care experts found “major discrepancies” province to province in the quality and completeness of vaccine risk information given to students and families.
The 2011 study said such information gaps can have “a significant effect on the legal validity” of consent.
“It’s concerning because it’s sending mixed messages,” said one of the study’s authors, Dalhousie nursing professor Audrey Steenbeek. An advocate of HPV vaccinations, she said better information will help curb distrust of vaccines.
The Public Health Agency of Canada says vaccines have saved more lives over the past 50 years than any other health measure, and have controlled serious diseases such as polio and measles.
Gardasil’s product monograph — a technical, 61-page document — devotes multiple pages to a range of common and rare side-effects, some serious, connected to Gardasil.
The parents of the young women in this story said the documents they received were sparse and omitted some of the side-effects included in the official document.
In Canada, when doctors, nurses, pharmacists or patients suspect a pharmaceutical or vaccine has caused a side-effect, they can file a report with Health Canada. The Star analyzed the regulator’s database of reports and found more than 50 “serious” incidents, including at least 15 hospitalizations connected to the vaccine since 2007.
In the U.S., where there is a public database of vaccine-related side-effect reports collected from around the world, the Star found thousands of suspected cases, including more than 100 deaths.
While the number and details of these reports may be concerning, it is important to note that since Gardasil was approved in June 2006, more than 169 million doses have been distributed globally, according to Merck.
Suspected side-effects listed in the Canadian reports include: Convulsions; more than 10 cases of joint, abdominal and other serious pain; two cases of anaphylaxis, a severe allergic reaction; two deaths, including that of a10-year-old girl; and a hemorrhage, stroke and life-threatening heart condition. In many of the cases, the patients were teenagers, often 13 or 14 years old.
A Health Canada spokeswoman said, “None of the adverse events reviewed have suggested any concerning trends or patterns linked to the HPV vaccines in Canada.”
The spokeswoman also said that the available data shows Gardasil to be “among the most efficacious vaccines.”
One of the side-effect reports in Health Canada’s database relates to 14-year-old Frédérick St-Germain’s heart attack.
St-Germain was hunting snow geese with her father and brother when she collapsed. It was October 9, 2010. She had received her first Gardasil vaccine nine days earlier.
St-Germain’s heart was stopped for 15 minutes before paramedics reached her rural Quebec home and resuscitated her, said her mother, Mylène Boisvert. She spent 34 days in hospital, six of them in an induced coma.
“I had to relearn everything, things that a 2-year-old would have to learn,” StGermain, now 18, told the Star.
Months later, after a battery of tests came up negative, a cardiologist reported to Health Canada and Merck that he suspected Gardasil caused the girl’s heart attack.
Many of the girls interviewed by the Star said that as they struggled to learn what was ailing them, doctors told them the illnesses were imagined, that they had eating or anxiety disorders, that the problems were in their head.
When Natalie Kenzie of London also developed digestive problems, “the doctors tried to convince me I had an eating disorder,” said Kenzie, now 17 and in Grade 12. A doctor made her cry, she said, when he told Natalie she was trying to harm herself.
“It’s very sad because what I see is the physicians are not accepting the fact that these young women have pain and issues,” said Dr. Diane Harper, who was the principal investigator of a major clinical trial for Merck as the company was developing the blockbuster vaccine for the worldwide market. “The docs in the trenches have been conditioned to respond, ‘vaccines don’t have side-effects.’ ”
Harper, now the chair of family and geriatric medicine at the University of Louisville in Kentucky, said Gardasil’s approval by the FDA was fast-tracked unnecessarily, since the progression of an HPV infection to cancer often takes decades and can be detected through regular pap screens. She said the vaccine could have been analyzed over a much longer time frame.
“There could be harm,” Harper said. “You just don’t know until you look at it in the full population.”
Merck said it monitors reported adverse reactions and, “while no vaccine . . . is completely without risk,” health regulators around the world continue to recommend its use.
But in promoting the vaccine, Harper said, health officials often omit the importance of still getting regular pap screens to protect from the HPV strains not covered by Gardasil.
The public is not only getting incomplete information about Gardasil from officials in Canada; there are also conflicting messages from other regulators around the world, a mix of red flags and reassurances that seem to only raise more questions.
In Japan, the health ministry announced in 2013 that it had received reports of individuals who received the HPV vaccine — the ministry did not specify whether it was Gardasil or another brand called Cervarix — and “experienced sustained pain for which a causal relation to the vaccine cannot be denied.” The ministry also said that “regular vaccination should not be actively encouraged” until more was known about the side-effects.
But a World Health Organization committee said there was little reason to suspect the vaccine as the cause considering the absence of similar problems in other countries. It said each case in Japan should be carefully documented and urged “a thorough search for a definitive diagnosis.”
And in the U.S., a review committee recommended against Merck’s application to get Gardasil approved for use among women aged 27 to 45 because company data did not show the vaccine to be effective in this age range.
But Health Canada saw it differently, and in 2011 licensed Gardasil for women up to age 45. “As the number of women with pre-existing infection increases with age, the overall benefit is not as great,” the regulator said. “However, there are populations of older women who can still benefit from the vaccine.”
Merck told the Star that the vaccine is approved for the older age range in more than 50 countries.
Jen Keats, whose Guelph doctor assured her the vaccine had no side-effects, received the shot at age 29 and subsequently experiences nausea, weakness and migraines. Keats’ doctor did not return messages left by the Star.
From her home in Laval, Que., Linda Morin, 55, recalled the night of her daughter’s drowning, when she returned home from the hospital and was questioned by two police officers. She did not, at the time, have an explanation.
Not until a few months later, when she read an article about two young Spanish girls who suspected Gardasil caused their hospitalizations, did Morin think she might have an answer.
She called her daughter’s school, asked some questions, took some notes and built a timeline.
Annabelle got her first Gardasil shot on Oct. 9, 2008. Morin remembered that on Oct. 25 Annabelle “came out of (her) room disoriented, she could hardly walk, she couldn’t speak. She was mumbling.” Annabelle was also vomiting and complained of a bad headache. Morin took her daughter to the hospital, where a brain scan turned up nothing. Soon Annabelle felt better.
The episode occurred 16 days after her first Gardasil shot.
Annabelle got her second shot on Nov. 24. After about the same span of time, 15 days later, she died.
Morin says that despite the coroner’s call for an investigation into the role Gardasil played in her daughter’s death, none occurred.
She sued Merck but abandoned the legal action in part, she said, because of difficulty finding a Quebec doctor who would say Gardasil contributed to Annabelle’s death.
“I am not against the vaccine,” Morin said. “I want people to be responsible about Gardasil. I am trying to inform people.” Data analysis by Andrew Bailey