Healthy Skepticism Library item: 18373

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Merck Finds A New Angle For Promoting Gardasil
Pharmalot 2010 July 8
http://www.pharmalot.com/2010/07/merck-finds-a-new-angle-for-promoting-gardasil/

Full text:

As Merck looks to extend the market for its Gardasil HPV vaccine to older women (back story), a new study finds the human papillomavirus shows up in young children whose airways may become infected while in the womb or during childbirth. As a result, children can develop wart-like lesions of the nose, pharynx, trachea and bronchi, a problem known as juvenile onset recurrent respiratory papillomatosis, or JoRRP, which can interfere with breathing and require surgical removal.
The study, which was published online in The Laryngoscope (subscription required), found that between 1994 and 2007, the overall incidence rate of JoRRP in children aged 14 and younger was only 0.24 cases per 100,000, or 243 reported cases (the prevalence rate was 1.11 per 100,000). And these required 3,021 surgical procedures. The median age at time of diagnosis was 4.4 years, and children with JoRRP underwent a median of seven surgical procedures.
“While the overall incidence of JoRRP is low, the implication for the afflicted children is significant and knowing the scope of the problem is critical,” says Paolo Campisi, associate professor in the University of Toronto Faculty of Medicine’s Department of Otolaryngology – Head & Neck Surgery and staff otolaryngologist and project investigator at SickKids Sickkids. in a statement. “Widespread vaccination against HPV within the female population may affect the incidence of JoRRP and spare children from the harsh consequences of the disease.”
The extent to which this is a big problem is unclear, but the implication is the market potential is huge, given that the statement goes on to say the cost of treating JoRRP in the US alone is $100 million annually. The incidence and prevalence, however, has only been examined in some parts of the world. “The majority of the reported epidemiological rates are derived from limited populations or from estimates and extrapolations,” according to the statement.
In any event, the study was funded, in part, by Merck and the Sickkids Foundation. The drugmaker, you may recall, has been repeatedly frustrated in its quest to widen the market for Gardasil. The vaccine is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts in males of the same age. But efforts to win FDA approval for women between 27 and 45 years old have been stymied (see here). Meanwhile, Gardasil revenue last year was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.
In any event, the study was funded, in part, by Merck and the Sickkids Foundation.