Last Thursday, the Toronto Star ran a front-page story on the Gardasil vaccine, describing the vaccine as having a “dark side”: debilitating illnesses. The headline and the story describe a supposed relationship between the vaccine and an array of serious adverse events:
What was the basis for the Star’s claim that the vaccine causes harm, and that risks are not being disclosed? The story primarily focused on interviews with women and their families who attribute different events to the vaccine. The Star went on to analyze Health Canada’s database and claims it found 50 “serious” incidents, including 15 hospitalizations. Studying the US adverse event database, the Star reported it found thousands of cases of harm, including more than 100 deaths. The implication the Star makes is clear: Harms and risks are not being disclosed to vaccine recipients. Yet while the cases the Star reviews are tragic and in some cases heartbreaking, the relationship to the vaccine is not established in any of the cases it profiles. A single sentence acknowledged the lack of actual evidence linking the vaccine to any of the adverse events it describes:
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.
Relying heavily on anecdote instead of objective scientific evidence, The Star implies causation when all it could show is correlation. The result was a classic “false balance” picture painted about the HPV vaccine’s safety – a gift to the anti-vaccine movement, which also relies heavily on anecdotes and emotion, rather than scientific facts. False balance is always a fear with vaccine reporting, particularly because “false balance” propagates unfounded fears, implying a scientific “debate” when the consensus says otherwise. Given viewing anti-vaccine messaging for a even few minutes can decrease intentions to vaccinate, it is essential, from a public health perspective, to communicate vaccine safety information responsibly. But that didn’t happen with the Star’s vaccine story. From the headline through the reporting, the story failed to communicate risk and benefit effectively. This is unfortunate, because the the HPV vaccine has been studied – extensively. There is robust, high-quality data that establishes its safety. And the Star presented no evidence to demonstrate that the harms of the vaccine have been misstated.
The HPV vaccine is safe and effective
The human papillomavirus (HPV) is the most prevalent sexually-transmitted infection in North America, and almost all cervical cancer is caused by HPV. HPV causes a substantial number of cancer cases every year. The HPV vaccine is an effective means of preventing cancer. There are two brands of the vaccine: Gardasil provides protection against four strains of the virus and Cervarix protects against the two strains that cause the most cases of cervical cancer. The vaccines are widely acknowledged to be effective. Multiple studies demonstrate that they lack serious side effects, and are well tolerated (See the CDC page for more.) The only harms that have been clearly linked to the vaccine are local reactions (pain, swelling) as well as the risk of fainting. The totality of all the published evidence establishes that the benefits of HPV vaccination outweigh the risks. Consequently it has been widely adopted into vaccination schedules worldwide. In Ontario, the program to vaccinate all girls started with the 2007 grade 8 cohort. The safety of the Ontario program has been evaluated and reported in the literature. In over 700,000 doses, the vaccine is very well tolerated:
But these reports, while reassuring, do not give us the entire picture. When we look at the best quality evidence, across different studies by different researchers, the safety profile of the vaccine is remarkably consistent. Large, high quality studies have concluded that the vaccine is well tolerated, without serious side effects. And these studies are the best evidence we have to determine the overall risk perspective. This is the information that is given to potential recipients of the vaccine, as it’s derived from the best quality evidence. These studies control for causality and give a better perspective than individual case reports. Yet the Star’s story focused on lower quality evidence: case reports. Then the Star made another error – it conducted a review of adverse reaction databases, without appearing to understand the significant limitations of this data.
Adverse event databases do not establish cause and effect
Antivaccinationists love the Vaccine Adverse Event Reporting System (VAERS). Diving into VAERS data led to the widely publicized (but easily refuted) claim that the HPV vaccine has killed over 100 women. VAERS is a surveillance system that anyone can report any adverse event to. It does not prove cause, or even that the reaction occurred at all. Do you believe that the influenza vaccine turned you into the Incredible Hulk? Report it. One scientist did just that to prove a point about the limits of VAERS. Vaccine litigation has also been shown to distort the VAERS database. It’s often used as as a “dumpster dive” for antivaccinationists intent on linking harms to vaccines. This isn’t to say that VAERS is useless – it’s the starting point for more safety studies. (The very rare side effect of intussusception from the rotavirus vaccine was detected from VAERS data.) Are the harms attributed to HPV in the VAERS reports likely to be real? The quality of these reports is, in many cases, low. Here’s one example of a case report linking the HPV to death that I have pulled from the database:
“Information has been received from a nurse practitioner concerning a patient’s nephew, a 17 year old male consumer who she “”thought”” was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as “”two weeks ago”” on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested.” [VAERS ID: 421582-1]
How the Star responded to criticism
In a 3 minute search on PubMed I found three articles that the reporter apparently “missed” (assuming, of course, that unbiased reporting was the goal). A 2014 study that shows no increased incidence of autoimmune disorders after HPV vaccination. A detailed reviewed of the VAERS data in JAMA in 2009 showing the adverse events after HPV vaccination with Gardasil “were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible under reporting) of a passive reporting system. no link between.”
But with the credit must come the criticism, and if Mallick’s response is a reflection of the culture within The Star, then there’s a problem. Her reaction of blocking people she doesn’t agree with, that she wants to get off Twitter as if we’re even blessed she’s on there to begin with, and other comments —- don’t read Gunter’s blog post, don’t read other media outlets with bald men, equivocating legitimate criticism with Tea Partiers — conjures up the image of a teenager plugging her ears saying “I can’t hear you”, all the while doing so in a condescending tone. But again, I’m not begrudging her desire to criticize with emotion.
The rest of Mallick’s piece just bears no sense at all, as far as I can tell. What does waning vaccine efficacy have to do with anything? A summary of the measles outbreak? Her whooping cough ailments? Flu virus mutability? Anti-vaxxing Queens University academics? I can only assume she meant the timing will never be right (but it certainly isn’t clear). But then Twitter’s deal with Google, huh? And apparently a book on epidemiology meant for the general public is boring so… let’s talk about hand-washing? I’m not following your train of thought.
Mallick’s confusing column, with her denigrating comment about Dr. Gunter being a “rural doctor” only exacerbated the criticism of the Star, and Mallick, on social media. Mallick refused to engage on Twitter in a meaningful way, and she started “blocking” academics, physicians and health professionals on Twitter who tried to explain the the problems with the Star’s story. The hashtag #blockedbyMallick followed. The Star’s story and its response to Dr. Gunter caught the attention of physician and author Ben Goldacre, who Mallick had name dropped in her column. Goldacre is a noted critic of the pharmaceutical industry’s habit of burying data it doesn’t like. But in an eviscerating series of tweets, he questioned both The Star’s and Mallick’s intentions:
Finally, as Julia Belluz describes today in a Vox column on the Star’s story, the Star continues to question the motives of its critics rather than respond in a meaningful way to the continued criticisms.
The Star has done some excellent reporting over the years about drug safety. But with this story, it missed the mark. I don’t think the Star is antivaccine, or it deliberately intended to propagate an antivaccine message. But by creating a manufactroversy about the HPV vaccine’s safety, it has done just that. The problem is not the case reports and the women and the families who have suffered. They deserve compassion and medical care. The problem is how the Star chose to report this story. It created fear, uncertainty and doubt about the HPV vaccine without giving the proper perspective – that the HPV vaccine is a safe vaccine. It gave its front page over to individual case reports of attributed harm, rather than acknowledging the high-quality data that has demonstrated that the HPV vaccine is safe and effective. It failed to emphasize that correlation does not equal causation. It failed to accurately convey that there is a very high level of scientific consensus that the HPV vaccine is safe and effective. Finally, it failed to show that the risks of the vaccine are not being communicated effectively.
Before we start attributing harms to public health measures, like vaccines, we have a public responsibility to make sure those harms are real. Uptake of the HPV vaccine is lagging in Ontario. This lag will mean more cases of preventable HPV and potentially, more preventable cancers. When it comes to dealing with unfounded fears about vaccines, vaccine expert Dr. Paul Offit has commented how hard it is to “unring the bell” of vaccine fear, and reassure people once you’ve scared them. With this story on the HPV vaccine, the Star rang that bell loudly. I hope that the Star will acknowledge and address the situation it has created.