Cold Facts about Gardasil? More like Intellectual Rigor Mortis

Kalla Fakta (roughly translates to “Cold Facts”) is an investigative program on Swedish television that has been on air since 1991. Among its many crowning achievements we can count exposing how the Swedish government let a CIA-led operation on Swedish soil deport two suspected terrorists and subject them to torture in an Egyptian prison (one of them was released and each got financial compensation equivalent to almost half a million USD) as well as shining a light on the Nazi connections of Walther Sommerlath (father of the Queen of Sweden) that was previously denied. Together with Uppdrag Granskning (roughly translates to “Mission: Scrutiny”), it is one of those investigative shows that typically sends chills down the spine of people anytime you get a phone call or visit from them; you instantly know you are in deep trouble.

However, even good investigative programs sometimes fall pray to pseudoscience. On April 21st, Kalla Fakta aired an episode called “The Vaccination Choice”, which was supposedly investigating the information teenage girls get about the HPV vaccine Gardasil. In reality, it was a compilation of classic anti-vaccine tropes and, astonishingly, one of their tactics was reminiscent of the HIV/AIDS denialists pseudodocumentary House of Numbers.

Let us investigate the investigators.

Study of over 600 000 Gardasil doses shows no association with Guillain–Barré syndrome

A study published in the journal Vaccine by Gee et al. (2011) examined over 600 000 doses of Gardasil given to girls and young women between 9 to 24 over four years. It showed that being a recipient of Gardasil did not increase the risk of Guillan–Barré Syndrome (GBS). Therefore, the evidence favors a rejection of the notion that Gardasil causes GBS. This is in stark contrast to the episode that appeals to an anecdote to argue for a causal relationship (see below)

Study of almost 200 000 women given Gardasil show no serious side-effects

A study published in the journal JAMA Pediatrics by Klein et. al. (2012) investigated almost 200 000 women who had been given Gardasil. After correction for multiple comparisons, only skin infection and fainting could be attributed to the vaccine administration. However, fainting is associated with injections given by needles to this age group in general and many skin infections were local reactions to injection.

No other issues were detected and they specifically looked for differences in hospitalizations and visited to the emergence department due to autoimmune conditions.

Gardasil was up to 93% effective against genital among vaccinated Swedish women

A study published in Journal of the National Cancer Institute by Level et al (2012) looking at over 120 000 young women showed that the Gardasil vaccine has 76% effective against genital warts for women vaccinated after the age of 20 and 93% effective against women vaccinated before the age of 14. The researchers concluded that the vaccine was effective at preventing genital warts and that the protection if vaccination occurs early.

Gardasil vaccination reduce incidence of genital warts with up to 93% in young Australian women

A study published by Hammad et al. (2013) in British Medical Journal showed a large decline in the number of new cases of genital warts in studied women between the ages of 21 to 30 (~73%) and women under the age of 21 (~93%). The researchers concluded that the Gardasil vaccine is highly effective in real-world settings.

Gardasil prevents against precancerous lesions with an effectiveness of 93%

The results of the PATRICA study was published by Paavonen et al. (2009) in The Lancet and it showed that the efficacy of the Gardasil vaccine against high-grade cervical intraepithelial neoplasia was ~93%. They also showed that it gave cross-protection against 12 other cancer-causing HPV types that was included in the vaccine (54% efficacy).

Reported side-effects are distinct from actual side-effects

Reported side-effects are events that happen to occur some time after vaccination. However, just because B occurs after A does not mean that A causes B. The rooster crows and then the sunrise occurs, but this does not mean that roosters cause the sunrise. Reported side-effects is not the same as actual side-effects that has been established by scientific studies. The episode of Kalla Fakta does not clearly distinguish between these two categories.

Financial compensation does not equal scientific evidence for causation

Sweden’s system of financial compensation is similar to the one in the United States. If you think you have gotten a pharmaceutical-induced damage, you file a report. This report gets investigated by someone at Läkemedelsförsäkringen (an organization created by voluntary pharmaceutical companies in the late 1970s, translates to “Pharmaceutical Insurance”) and if the insurer approves it as a case of pharmaceutical-induced damage, the person gets financially compensated.

Läkemedelsförsäkringen uses the principle of no-fault, which means that you can get compensation even if it is not clear how the drug caused the damage and even if the company did no wrong. The burden of evidence is also strongly reduced and the claimant only has to show that it is more likely than not that it was due to the drug rather than having to establish it beyond reasonable doubt (Läkemedelsförsäkringen, 2013).

The show focuses a lot of a single case of a young women who appeared to have developed Guillain–Barré syndrome (GBS) after being vaccinated. However, as we saw above, Gardasil probably does not cause GBS. At any rate, she filed a complaint and got an economic compensation. This is taken as evidence for a causal relationship. However, the fact that an insurer approved compensation does not mean that science has established a cause-and-effect relationship.

“Protection against cervical cancer” does not indicate “100% effective”

The program also complains about how information by the health care system claims that Gardasil protects against cervical cancer. They claim that it suggests that the protection is 100% when it is only 70% and that it is unreasonable to say that it protects against cervical cancer when the research has only shown that it protects against precancerous lesions and that it might lead to women stop doing pap smears.

However, both of these claims are themselves flawed: (1) saying that something is protective does not suggest that it protects 100% and some information even states the 70% figure and (2) as far as we know, you need to get precancerous lesions before getting the full-blown cervical cancer, so if it protects very well against the precancerous lesions, then it should protect against developing full-blown cervical cancer as well.

Another written criticisms of the Kalla Fakta episode posted at the website of a national health care related hotline called Vårdguiden (roughly translates to “Care Guide”) explains that the information card that Kalla Fakta complained about is given in an envelop that also contains papers with additional detail. This additional information explains that it is a vaccine against the HPV strains that cause 70% of cases of cervical cancer and that it is important to continue doing pap smears (Vårdguiden, 2013).

Exploiting the errors of a single nurse

Instead of asking scientists or investigating the scientific literature where they would have gotten evidence-based responses to all of their thoughts, they decided to try the same trick as the producers of the HIV/AIDS denialist pseudodocumentary House of numbers did: talk to a single, random nurse without knowing her expertise and hope she gets the facts wrong, then attempt to portray it as systematic abuse of patients by the system.

Kalla Fakta records a young girl (who was thinking about getting the vaccine) calling Vårdguiden to see what information they provided. They show the young woman talking to an older female nurse over the phone and the female nurse, being a single individual and not a scientific expert, incorrectly said that the HPV virus cause genital warts that in turn can develop into cervical cancer. The correct explanation would be that the virus cause a specific type of precancerous lesions called “high-grade cervical intraepithelial neoplasia” that in turn can develop into full-blown cervical cancer.

Yes, she got part of the cancer-causing mechanism wrong, but it is completely unjustified to exploit this error in the way that Kalla Fakta did and suggest that this implies the existence of a systematic problem with the provision of vaccine information.

Conclusion

Kalla Fakta made an enormously flawed and pseudoscientific program that repeated many of the anti-vaccine myths about Gardasil.

Gardasil is a very safe vaccine and the evidence favors a rejection of a causal relationship between the vaccine and Guillain–Barré syndrome.

Gardasil is also very effective, being over 90% effective against genital warts and precancerous lesions.

As an investigate program, Kalla Fakta has an intellectual responsibility of standing up for reason and evidence. This time, Kalla Fakta failed miserably at this task.

Addendum

After the show, I had a short twitter conversation with the host of the show, the journalist and author Lena Sundström (@LenaSundstrom). She is an incredibly skilled and powerful journalist and persuasive in almost everything she does. My absolute favorite was a documentary she did exposing right-wing anti-immigration forces in Sweden. Therefore, I have the utmost intellectual respect for her. However, after the airing of this episode of Kalla Fakta and the twitter conversation, I will have to rethink this a little bit.

The twitter conversation (played out on the hashtag #KallaFakta) started with me linking her the Gee et. al. study. She did not reply. I tweeted her that I had reported the show to Myndigheten för TV och Radio, which investigates TV shows to see if they break the TV and Radio law. No reply. She then responded to another person (suggesting that she should take a job at an anti-vaccine organization) by stating that she vaccinates her children, so she did not understand how he could label her as anti-vaccine. I replied by pointing out that if you spread incorrect statements, such as “Gardasil can give GBS”, then that is being anti-vaccine. She replied that I then would have to label FASS that as well (FASS is a generally recognized source for medical information about pharmaceuticals licenced in Sweden).

I countered by saying that FASS does not list GBS under known side-effects, but under reported side-effects. She dodged the issue and said that they had been very careful with this and that the cases they discussed in the show had been determined to be caused by Gardasil. I replied that there is an important difference between what an insurer concludes and scientifically established causation. She replied by saying that they did separate all these differences and that I should email my objections as 140 characters only lead to misunderstandings.

However, I decided to not carry on the argument with her because, from the perspective of scientific skepticism and evidence-based debunking, it is probably not cost-effective to argue with a single oppositional individual via email. That is one of the reasons I decided to write this blog post.

References

Paavonen, J., Naud, P., Salmerón, J., Wheeler, C. M., Chow, S. N., Apter, D., . . . Dubin, G. (2009) Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. The Lancet, 374(9686), 301-314.

Gee, Julianne, Naleway, Allison, Shui, Irene, Baggs, James, Yin, Ruihua, Li, Rong, . . . Weintraub, Eric S. (2011). Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink. Vaccine, 29(46), 8279-8284.

Ali, Hammad, Donovan, Basil, Wand, Handan, Read, Tim R H, Regan, David G, Grulich, Andrew E, . . . Guy, Rebecca J. (2013). Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ, 346.

Klein Np, Hansen J. Chao C., & et al. (2012). Safety of quadrivalent human papillomavirus vaccine administered routinely to females. JAMA Pediatrics, 166(12), 1140-1148.

Leval, Amy, Herweijer, Eva, Ploner, Alexander, Eloranta, Sandra, Fridman Simard, Julia, Dillner, Joakim, . . . Arnheim-Dahlström, Lisen. (2013). Quadrivalent Human Papillomavirus Vaccine Effectiveness: A Swedish National Cohort Study. Journal of the National Cancer Institute.

Läkemedelsförsäkringen. (2013). Om LFF. Accessed: 2013-04-23.

Vårdguiden. (2013). Vårdguidens information om HPV-vaccination . Accessed: 2013-04-23.