On February 5, 2015, the Toronto Star published an investigative article headlined “A wonder drug’s dark side.”[1] The story was on the front page, above the fold. It was endorsed in an editorial. It emphasized that at least 60 young Canadian women had suffered serious health problems after receiving a shot of the anti-cancer HPV vaccine Gardasil, manufactured by Merck & Co. One had died, another had needed a wheelchair, still another had to use a feeding tube. A basis for the story was that patients and families believed the vaccine had dangerous side effects and presented risks that were downplayed or kept from view by the medical community. The Star was openly supportive. It wrote: “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,” and that in another database, in Canada, it had “found more than 50 ‘serious’ incidents, including at least 15 hospitalizations connected to the vaccine” and two deaths. The Star also said: “The public is getting incomplete information about Gardasil from officials in Canada.” The article came with heartbreaking online video testimonials.

Gardasil is as safe as a vaccine can be. Documented side effects are rare and generally mild. It did not cause the problems described in the article. The suggestion that the vaccine has underreported, serious and sometimes lethal side effects is baseless. Intense criticism followed the publication, leading to the article and video to be “unpublished” by the Star.

Gardasil is very effective at protecting against several strains of human papillomavirus (HPV). This sexually-transmitted infection can result in various forms of cancer, including cervical cancer. Although no vaccine or drug can be said to be 100% risk-free, as of this writing Gardasil’s safety is a scientifically demonstrated fact.

The 72-paragraph, 2,500-word story presented many problems, including:

1) The stories of the “victims,” told in dramatic detail, were put front and centre, while actual facts about the vaccine’s safety were either ignored or, as one critic would write, “embedded obscurely.”[2] For example, the statement “there is no conclusive evidence showing the vaccine caused a death or illness” was sandwiched between the description of a teenager’s tragic death and allegations that the drug was being “pushed” on young girls by school officials.

2) The reporters had no proof, standard-bearer or whistleblower. No doctor, scientist or health official, even anonymously, supported the idea that Gardasil presented a higher risk than advertised and sometimes caused serious health issues. The reporters were careful not to write in so many words that the vaccine was the culprit. Once being served with dubious factoids and omissions that pointed in the “right direction,” readers were emphatically told what patients and families “believed,” then left to connect the dots.

3) The reporters did not name and had not talked to any of the doctors who, the Star would say, had reported most of the cases mentioned in the piece.[3]

4) The research behind the Star piece was flawed. In addition to the cases that reportedly came from unidentified doctors, the reporters had roamed through the U.S. Vaccine Adverse Event Reporting System (VAERS) and a similar Health Canada database, where medical events that might be related to a vaccine or a drug are collected, waiting to be analysed for patterns by experts. To illustrate the extent to which such data cannot be taken at face value, a doctor once filed an entry claiming the influenza vaccine had turned him into the Incredible Hulk, and his entry would have stayed there had he not voluntarily removed it.[4] In short, these databases are repositories for raw data that are meaningless until processed, and the Star’s reporters had unwittingly retrieved coincidences.

5) Remarkably, a study of the VAERS data, commissioned by the U.S. Centers for Disease Control and Prevention, did exist. It had taken place years earlier and had showed that the Gardasil vaccine was safe. Conclusions had been published in JAMA: Journal of the American Medical Association in 2009. Neither the study nor the article was mentioned in the Star.[5]

6) The article contained questionable allusions to purported international “red flags” and “alarms” from health regulators abroad. These were emphasized early (par. 18), but only described much deeper in the piece (par. 58-60). One such alleged red flag was that the U.S. had decided to recommend against the vaccine manufacturer’s application to have Gardasil approved for women over age 27 because it was not considered effective at that age. This has nothing to do with side effects and does not qualify as a red flag. The second so-called red flag referred to Japan, where the Health Ministry had decided to “stop promoting” HPV vaccination after receiving reports of side effects. But the Star itself explained that the World Health Organization disagreed with Japan’s decision and had said “there was little reason to suspect the vaccine [was] the cause, considering the absence of similar problems in other countries.”

In sum, consciously or not, the Star’s article had been framed to cast significant but unwarranted doubts on the safety of a life-saving vaccine. According to critics and observers, the reporters had hyped anecdotes, drawn erroneous conclusions from data they did not understand and brushed available scientific evidence under the rug, and in so doing had fuelled the anti-vaccine movement and potentially imperilled lives.

Critics started challenging the Star immediately. Dr. Jennifer Gunter, a San Francisco-based, board-certified obstetrician-gynecologist and pain medicine specialist with a fellowship in infectious diseases, wrote a blog on February 5 detailing why the Star’s piece was biased and on the wrong side of science. She explained that the data had been misunderstood and misrepresented, and that studies had been ignored by the Star. The following day, Dr. Gunter was publicly dismissed as a “rural doctor” by Heather Mallick,[6] a Star columnist, prompting vigorous online responses by pharmacist and blogger John Greiss[7] and Dr. Ben Goldacre, a British physician, academic and science writer, who on Twitter spoke of “crass, outdated, appalling, ignorant, irresponsible journalism” after reading the Star article.[8]

Julia Belluz, an award-winning journalist covering medicine and public health, who was a 2013-14 Knight Science Journalism Fellow at MIT, contacted the Star to question the story. She was told to “stop gargling our bathwater and take the energy to run yourself your own, fresh tub.” Belluz’s piece, “How the Toronto Star massively botched a story about the HPV vaccine,” was published in Vox.com on February 10.[9] Also on the 10th, pharmacist Scott Gavura chimed in with “The Toronto Star’s gift to the antivaccine movement,” which explained in a blogpost that the Star had “created fear, uncertainty and doubt.”[10]

Around February 10, the Star received a letter to the editor[11] co-signed by Juliet Guichon, of the University of Calgary, recipient of the Canadian Medical Association Medal of Honour for HPV vaccine-related work, and Dr. Rupert Kaul, professor in the departments of medicine and immunology, and Head of the Division of Infectious Diseases at the University of Toronto. The letter, signed by 63 other specialists and academics from across Canada, explained the vaccine was safe, and that the Star reporters had mixed correlation and causation. “Serious” side effects were very rare, it said, and amounted to allergic reactions. The letter also stated: “Study after study has shown that there is no causal link between the events the Star reported and the vaccine. About 169 million doses of the HPV vaccine have been administered worldwide. In any given large population, there will be illness and death. This is a statistical fact. To attribute rare devastating occurrences to a vaccine requires evidence of causation, of which the international scientific community and the Star article have none.” The letter was published in the Star on February 11 on page 17.

In The Walrus, journalist Jonathan Kay wrote that the Star story was “grossly misleading” and that readers could get “the impression that this vaccine is dangerous…” while the “risk of dying from taking the HPV vaccine… is zero.” Kay assumed “[the reporters and their assigning editor] did not understand science or statistics… None of those people had the basic scientific literacy to know what they were putting on the front page of Canada’s biggest newspaper was misleading tripe.”[12]

The Star now recognized there was a problem, but not with the story itself. Publisher John Cruickshank publicly said: “We failed in this case… And it was in the management of the story at the top… The headline was wrong… the front-page play was a mistake.” Cruickshank also said he understood “why readers would wrongly take away from the piece that the drug is dangerous” but emphasized the article mentioned there was “no evidence” linking the vaccine to the health problems described.[13]

On February 13, an editor’s note in the Star conceded: “There is no scientific, medical evidence of any ‘dark side’ of this vaccine,” and the headline was changed online to “Families seek more transparency on HPV vaccine.” The words were different but the new headline’s meaning was the same: there were untold risks. In her blog, Dr. Gunter quipped: “They just don’t get it, do they?”[14] She had already asked, in vain: “What specific risk is the Toronto Star implying that doctors and nurses are keeping from their patients?”[15] In a letter published on February 14 by the Star, Dr. Joan Robinson, Chair of the Canadian Paediatric Society’s Infectious Diseases and Immunization Committee, wrote: “The reason why patients are not told about possible serious side effects is that, to date, worldwide, none has been found to be more common in Gardasil recipients than in the general public.”

For Star editor Kevin Donovan, who had overseen the assignment, the article and its research work were unimpeachable. He wrote: “I stand by the story and the reporting on the story. The reporters on my team investigated serious reports on a government health database… filed by doctors and others who lodged the reports with the Canadian government database because they were concerned about serious illness, and in one case death. This is a public database that is in existence to provide post-market surveillance of drug products, an important part of the health regulation system in our country. The reporters investigated and conducted interviews.”[16]

The Star’s public editor, Kathy English, who had raised questions internally immediately after the story was published, disagreed. Her commentary appeared on February 13. She blamed the headline and front-page placement (“the proven and stated fact of the vaccine’s safety was seemingly lost to too many… largely due to the dramatic front-page presentation”) but she went much farther when she also acknowledged that criticisms from the medical community were legitimate and that the article had been “alarmist” and a “journalistic misstep.” She wrote: “In looking at all of this, I have to wonder why the Star published this at all… If there is no proof that any of the young women’s illnesses, or the 60 adverse reactions in the database, were caused by the vaccine, then what is the story?”

English’s article contained an apology by the Star’s editor-in-chief, Michael Cooke: “I apologize to our readers and to the people in the medical community, and especially to those who believe our story could be used to fuel the anti-vaccine movement. There was a bad story-management combination approved by me: a foreboding headline, undue emphasis on the front page and terrible timing.”[17]

On February 13, the Los Angeles Times wrote that the Star’s reputation was “in tatters” due to an “evidence-free, bungled” investigation.[18]

On February 20, the article and the video were “unpublished” from the Toronto Star’s website. The reason given by the Star was: “We have concluded that in this case our story treatment led to confusion between anecdotes and evidence.” The February 5 editorial[19] and the Mallick column were not removed and remain online, without cautionary notes.

In a note to readers, publisher Cruickshank reiterated that the story’s aim had been to explain that “acknowledged risks are not always properly communicated” and blamed the situation on the “weight of the photographs, video, headlines and anecdotes,” not flawed research, sourcing issues, inaccuracies and omissions. The problem, he offered, had been that “some[20] doctors and public health officials were troubled by the story’s treatment and by the lack of reference to the many studies which conclude the risks of Gardasil are low” and the public had misunderstood the story. He also wrote: “Now that tens of millions of young women have taken the vaccine, it is conceivable that very rare reactions may emerge that weren’t identified earlier.” The note contained no apology.[21]

Was this an investigation, which normally entails actual findings, or was it some human-interest story masquerading as a scoop? Should the public accept stories that include language implying they may be groundless? To what extent, and under which conditions, should the conditional tense be allowed in reporting, given the oblivious risk of creating or propagating rumours?

Pushback to the Star’s story was immediate, compelling and public. Many of the critics were highly credible. Yet, no significant result was achieved for five days. Those who dared challenge the story during this period were either ignored or dismissed, sometimes offhandedly. There were no signs, before February 11, that the Star had any inclination to take a fresh look at the story. John Cruickshank told me that all newsrooms have to face negative reactions to their stories on an almost daily basis.

Indeed, to fulfil their mission as “watchdog” and serve the public interest, the media need to vigorously defend their work. Otherwise, there is a real risk that those who shout the loudest set the agenda. On the other hand, we expect the press to not confuse an engaged and knowledgeable audience with the so-called trolls. Is the press the “public square” where the “market of ideas” can flourish, or is it where the truth is decreed? For the media, standing by a story is apparently a default setting. Admitting mistakes, or even accepting the possibility of one, seems very difficult, almost anathema.

Letters to the editor may not be the best way to challenge hard-news content. Rebuttals offer the media an opportunity to falsely represent a situation as two-sided and contentious, providing them with an excuse for not acknowledging a straight-news story as defective. Fact-based criticism is framed as dissenting opinion, essentially to keep the conversation away from basic journalistic standards and avoid a correction or retraction.

The letter from Guichon and Kaul did not seem to accomplish much if the objective was to obtain a correction or a retraction. It did made an impression at the Star, and it was taken seriously, but publisher Cruickshank told me it played no role in his decision to unpublish. Rather, that decision was based on his own journalistic concerns about the work, and expert opinion he solicited.

When we spoke in December 2015, John Cruickshank agreed that the Gardasil story had been wrong and that “there [had been] failure in reporting and failures in every level of editing and oversight.” He added that the Star’s “analysis of the post-injection event data wasn’t informed by a coherent understanding of the well-established risk profile of Gardasil. This was made far worse by the presentation and headline treatments which indicated that the handlers of the story didn’t understand the story itself, much less the story’s imperfections…” He also said: “The crux of the problem was the reporters’ failure to understand the statistical significance of the vast testing and close study of Gardasil. Some of the events the stories reported could not have been caused by the drug on a purely physiological basis. Many others were statistically extremely improbable, virtually zero…”

At first sight, “the public,” or at least an informed, engaged subset of the public, played a role in bringing the Star to account, whereas the more “classical” approaches to accountability, including a letter to the editor and the public editor’s action, did not seem to have worked. But when considering all the circumstances and the outcome, the case for the “fifth estate” as an agent for getting the media to correct the record remains unconvincing. What we had here is a high profile, life-and-death story that was visibly flawed; it was challenged by credible academics, doctors and journalists who considered the story disastrous and explained why; no credible source from the medical community showed up in support of the story’s thrust. Yet, the story was never officially acknowledged to be wrong, this at a top-tier media outlet which takes accuracy, science and accountability seriously.

This suggests two hypotheses that I find not very reassuring in the era of “alternative facts.” (1) Within the media at large, problematic stories bearing on more mundane issues, and attracting less passion from independent critics, will typically never be corrected or retracted. (2) Because they mostly use alternative channels, challenges from the so-called “fifth estate,” as credible and forceful as they may be, get little attention from the general public; the media know this, and conclude that denial is a better strategy than admitting a problem; self-interest eventually takes precedence over the public interest.

© Michel Lemay

My thanks to John Cruickshank, who kindly accepted to answer a few questions.

This paper is a shortened, adapted version of Le cinquième pouvoir en action : le Toronto Star et le Gardasil, originally published in French as Chapter 7 of Le cinquième pouvoir, la nouvelle imputabilité des médias envers leurs publics, edited by Marc-François Bernier, from the University of Ottawa (Presses de l’Université Laval, 2016). Anyone interested in getting the full-length English version can contact me by email.

 

 [1] BRUSER, David, and McLEAN, Jesse, Families seek more transparency on HPV vaccine (originally: A wonder drug’s dark side), Toronto Star, February 5, 2015.

[2] KAY, Jonathan, Dropping Science, thewalrus.ca, February 12, 2015. http://thewalrus.ca/dropping-science/

[3] Paragraph 14 of the article, which contained a list of the sources, did not mention the doctors. The Star did not respond to allegations that among the said “doctors” were a chiropractor or a naturopath. http://www.cbc.ca/radio/asithappens/lynching-report-badger-nf-flood-risk-space-museum-rocket-and-more-1.2960346/we-failed-toronto-star-publisher-says-the-paper-s-hpv-vaccine-article-let-down-readers-1.2960366

[4] GORSKI, David. How not to report about vaccine safety issues, Toronto Star edition, February 16, 2015.

[5] GUNTER, Dr. Jennifer, Explaining Gardasil girls and HPV vaccine safety to the Toronto Star and Heather Mallick, February 9, 2015, and The Toronto Star’s HPV Reporting is a Disaster, February 10, 2015. (Dr. Gunter’s blog can be found at https://drjengunter.wordpress.com)

[6] MALLICK, Heather, Vaccine debate is one we shouldn’t even be having: Mallick, Toronto Star, February 6, 2015.

[7] GREISS, John. http://opined.ca/2015/02/response-heather-mallicks-column/

[8] https://storify.com/karengeier/when-teaching-yourself-statistics-is-no-match-for.

[9] BELLUZ, Julia. How the Toronto Star massively botched a story about the HPV vaccine, Vox, February 10, 2015. http://www.vox.com/2015/2/10/8009973/toronto-star-hpv-vaccine

[10] GAVURA, Scott. The Toronto Star’s gift to the antivaccine movement, February 10, 2015. https://sciencebasedpharmacy.wordpress.com/2015/02/10/the-toronto-stars-gift-to-the-antivaccine-movement/

[11] GUICHON, Juliet and KAUL, Dr. Rupert, Science shows HPV vaccine has no dark side, Toronto Star, February 11, 2015.

[12] KAY, Jonathan, op. cit.

[13] CBC, As It Happens, February 11, 2015. http://www.cbc.ca/radio/asithappens/lynching-report-badger-nf-flood-risk-space-museum-rocket-and-more-1.2960346/we-failed-toronto-star-publisher-says-the-paper-s-hpv-vaccine-article-let-down-readers-1.2960366

[14] GUNTER, Dear Toronto Star, your Gardasil article isn’t about transparency, February 16, 2015.

[15] GUNTER, op. cit., February 12, 2015.

[16] DONOVAN, Kevin, Toronto Star’s Head of Investigations Stands by HPV story, February 12, 2015. http://canadalandshow.com/article/toronto-stars-head-investigations-stands-hpv-story.

[17] ENGLISH, Kathy, Public editor criticizes the Star’s Gardasil story, February 13, 2015.

[18] HILTZIK, Michael, How a major newspaper bungled a vaccine story, then smeared its critics. Los Angeles Times, February 13, 2015.

[19] Make sure girls and parents know any risk with HPV vaccine, Toronto Star, February 5, 2015.

[20] At first sight, nearly a hundred doctors, scientists or health officials expressed disagreement with the article. English has signalled that the World Health Organization, the U.S. Centers for Disease Control and Prevention, the Public Health Agency of Canada and Canada’s National Advisory Committee on Immunization agree that the vaccine is safe.

[21] A note from the publisher, February 20, 2015.