As we explained in our last blog post, the medical profession has an ethical obligation to explain both the risks and the benefits of any drug to a patient so that the patient can make an informed decision about whether or not to follow the doctor’s recommendation. This is particularly true for vaccines, which are generally given to healthy people who may never contract the disease against which the vaccine is supposed to protect them.
If a physician fails to do so [i.e. fully explain costs and benefits] and/or if financial interests take precedence over public health, breaches of informed consent guidelines may occur. For instance, presenting information in a way which promotes fear of a disease while undervaluing potential vaccine risks is likely to encourage patients to give consent to the treatment, even when the latter has no proven significant health benefit.
There is significant evidence to suggest that the way in which the HPV vaccine was marketed in America (and indeed, the rest of the world) was not in line with current medical ethics. In fact, the vaccine was marketed to create a palpable sense of fear of cervical cancer among the public – particularly young women – even though, as we mentioned last week, the rate of cervical in the U.S. is actually not that high.
In America, the vaccine was initially marketed through ‘educational campaigns’ funded by Merck, the manufacturer of Gardasil, at professional medical associations (PMAs). This was a particularly clever tactic, since doctors rely on PMAs to provide them with evidence-based data, which they then use to inform their patients as to a drug’s risks and benefits. By targeting PMAs and using them as part of their marketing technique, Merck ensured that it was the main provider of the information doctors use to decide about vaccine effectiveness. In other words, your doctor very likely bases his or her attitude towards Gardasil on the information he or she received from Gardasil’s manufacturer, instead of some independent research authority.
A 2009 Special Communication from the Journal of the American Medical Association explores this particular marketing tactic, noting that, “By making this vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk [women in developing countries] practically ignored.” As a result, in 2006, Gardasil was named the pharmaceutical “Brand of the Year” for building “a market out of thin air.” It’s no wonder that, according to Merck’s CEO, the campaign proceeded “flawlessly.”
The complete disregard for medical ethics seems to be a feature of the HPV vaccine marketing campaign. In India, a clinical trial of the vaccine was abandoned after an investigation revealed that the trial violated national and international guidelines regarding clinical research as well as the rights of children. There, as in the U.S., the vaccine had been marketed to medical associations, whose uncritical acceptance of the manufacturer’s claims resulted in this completely unethical study that lead to the six post-vaccination deaths. Meanwhile, in France, several Gardasil advertisements were found to violate national health codes as they made false claims regarding vaccine effectiveness.
Back in the U.S., Merck spent billions of dollars lobbying to make the vaccine mandatory. As the report notes, “According to an editorial from The American Journal of Bioethics, even those who strongly favoured [sic] the vaccine were ‘stunned at the degree to which Merck has pushed its $400 vaccine as a mandatory measure.’” This is to be expected from a pharmaceutical company; however, one of the more troubling aspects of the vaccine’s promotion is the extent to which health authorities colluded with the vaccine manufacturer to market the vaccine through fear-mongering and providing misleading information. For instance, as we mentioned last week, both the FDA and the CDC promoted the claim that cervical cancer is the second-most common cancer among women worldwide, but neither clarified that 88% of cervical cancer deaths occur outside the U.S., or that cervical cancer can be prevented through regular pap screenings. Also, there is nothing to support the claim (made by the FDA and the CDC) that Gardasil is “an important cervical cancer prevention tool.” As we explained last week, no such data currently exists.
It is clear that the marketing of the HPV vaccine violated public trust in the medical profession, and indeed, took advantage of the medical profession’s trust in their own associations. In doing so, it withheld important information regarding the vaccine’s efficiency and effectiveness, emphasizing profits over all.