You'd think drugmakers would learn that delaying data is a bad idea. But GlaxoSmithKline still held onto its head-to-head study of its HPV vaccine Cervarix versus Merck's Gardasil for 14 months after the fact. And now that it's planning to release the research, experts are coloring themselves skeptical.
The delay, plus the fact that Glaxo is announcing the results at a less-than-major medical meeting, "has both my eyebrows up," Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics told Bloomberg. And Aaron Kesselheim, a pharma epidemiology expert, may have spoken for the masses when he told the news service, "If you have positive results, wouldn't you want to get it out? If it's negative, people should know that soon. It's concerning to me that the turnaround time for getting the data out there is so slow."
Glaxo says that it specifically chose the International Papillomavirus conference to present the study because it's "internationally renowned." And the company wanted to present the Cervarix vs. Gardasil trial along with another Cervarix study that tracked the vaccine's effects on more than 18,000 women--which explains the delay.
Glaxo has been trying to get a leg up on Merck ever since Gardasil hit the market ahead of Cervarix . Glaxo managed to win a U.K. contract as the official HPV vaccine provider, but it still hasn't persuaded the FDA to approve Cervarix in the U.S. Meanwhile, the market for HPV vaccines could be dwindling; Merck's Gardasil sales took another big hit in the first quarter despite big-time DTC advertising.
We'll have to wait till May 10 to see what the head-to-head trial reveals. Until then, the skeptics will keep talking.
- read the Bloomberg story