JAMA 8/19/09 – In case the Gardasil vaccine wasn’t already surrounded by enough controversy – now there is concern over its safety profile and the marketing practices of Merk. An article in JAMA presents the safety surveillance data for qHPV, finding that “Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events”
An accompanying editorial discusses the extensive marketing to and through medical professional organizations via the use of manufacturer – designed educational matierials (i.e. brochures, posters, etc)
Some of the adverse event rates can sound pretty scary, especially the 32 reports of death and the elevated rates of VTE. But there are big problems with the use of VAERS data to assess risk because the reporting comes from a variety of sources, with differing levels of detail and its hard to take away any understanding of causation at all. For example 90% of the patients with VTE had at least one other risk factor. It would be great to rely solely on the controlled safety trial data but they will never have the raw numbers to catch rare events that is found with broad observational data.
The other issue with Gardasil is that there are still many unanswered questions about efficacy. It is unclear what impact this will truly have on cervical cancer rates for many reasons. First, the duration of immunity is unclear. Second, there are several oncogenic strains of HPV that are not covered in the vaccine. And third, proper routine screening is readily available and significantly decreases the risk of developing cervical cancer. Just the fact that screening still has to be done regardless of vaccination status is going to make patients wonder about the point of even getting the vaccine.
All of this seems to add up to many potentially difficult conversations with parents to try to address in the context of a 15-minute office visit – but I’m pretty used to running behind at this point….