Was Gardasil overhyped?

The New York Times carried an article in the August 29, 2008 edition asking if the media should be blamed for Gardasil hype. Gardasil, the vaccine that it touted as preventing cervical cancer, has progressed through three stages of media frenzy. First, there was the initial burst of publicity surrounding its introduction, then there was the burst of publicity surrounding efforts of conservatives to discourage its use, now there is the all too predictable burst of publicity asking whether early reports on Gardasil were overly optimistic.

The irony is that nothing about Gardasil or its use has changed. We have the same information now that we possessed when the vaccine was introduced. Did the media overhype the introduction of Gardasil? Yes, it did, but that’s because it appears that no one read the scientific literature before writing about it.

Were the media improperly influenced by the Gardasil marketing campaign? The marketing campaign made claims that, thus far, are only extrapolations from existing data. The manufacturer did not lie, but the manufacturer does not yet know what the long term protective effect of the vaccine will be. The fact that the media looked to the marketing campaign for information was improper. Scientific claims can only be evaluated by looking at the scientific evidence. A marketing campaign does not provide a complete view of the scientific evidence.

Cervical cancer is caused by certain strains of the human papilloma virus. The virus also causes genital warts and pre-cancerous changes in the cervix. The vaccine causes the body to produce antibodies against the virus. Initial testing has been very promising; women who received the vaccine did not develop genital warts and did not have detectable levels of virus on testing. In contrast, some women who received the placebo did develop genital warts, and the virus could be detected on tests.

So far, so good. The vaccine appears to offer excellent protection against the HPV virus, and appears to prevent the development of genital warts. Does the vaccine prevent cervical cancer? No one knows, because it takes many years for cervical cancer to develop after exposure to HPV, and the vaccine has not been around for many years. Theoretically, it will prevent cervical cancer, but only if the strains in the vaccine are the only strains that can cause cancer, and only if protection is long lasting. We have little or no information on these issues.

Did the media overhype Gardasil? Of course it did. The media, like the manufacturer, claimed that Gardasil will prevent cervical cancer, but no one actually knows if that is true. It will take years to determine whether Gardasil prevents cervical cancer.

But wait; does that mean that the manufacturer should be prohibited from claiming that Gardasil can prevent cervical cancer? Does that mean that girls should not receive the vaccine? Those are difficult ethical questions. Gardasil probably does prevent cervical cancer, but we won’t know definitively for a decade or more. In the meantime young women who forgo the vaccine because it hasn’t been proven to prevent cervical cancer might be forgoing protection against a deadly disease. We know the virus causes cancer. We know that the vaccine helps the body fight off the virus. Logically, we expect that the vaccine will prevent cervical cancer.

How sure do we need to be before we should recommend widespread use of the vaccine? The government decided that given all the available evidence, the projected benefits appear to outweigh any risks, and they are probably right. However, the truth is that no one really knows if Gardasil prevents cervical cancer.