HPV vaccine promoted with drug company money
Two new studies shed light on the safety of the vaccine to protect women from cervical cancer and call into question the ethics behind the marketing of the shot.
Gardasil, the blockbuster vaccine to combat the human papillomavirus (HPV), which can cause cervical cancer, is linked to complications, including 32 deaths, according to an analysis in today's Journal of the American Medical Association. But researchers note that the rate of side effects is low and the safety record is not out of line from other similar vaccines. The most common side effects are fainting, nausea and dizziness at a rate of about 40 to 80 cases per 1 million girls vaccinated.
Raising more eyebrows, however, is an accompanying JAMA article revealing that the makers of Gardasil, Merck & Co, provided grants to professional medical associations to help promote the vaccine.
"However, much of the material did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits," the authors note.
With some 23 million doses nationwide since its FDA approval in 2006, Gardasil has been marketed heavily with commercials depicting young girls chanting they would become "one less." Approved for girls and women ages 9 to 26, worldwide sales reached $1.4 billion in 2008. Still, the vaccine has been controversial from the start.
By marketing it as an anti-cancer vaccine, the company tried to avoid unease from parents and the public about how HPV is spread -- through sexual contact, increasing the threat of cancer to all adolescents, while ignoring the subgroups that are most at risk, said authors Sheila M Rothman and David J Rothman of Columbia University's school of public health.
Merck told the Washington Post that it gave professional groups funding for educational programs on the vaccine, but didn't tell the groups what to say.
Still, the Rothmans don't mince words when taking on the big drug maker and the professional medical organizations (PMAs):
That these arguments were delivered by PMAs is a cause for concern. Professional medical associations are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients. To this end, PMAs must become more transparent about their relationship with the industry, disclosing both the precise funding and technical assistance they have received to develop and disseminate the promotional products.