Delayed Glaxo Cancer-vaccine Study Raises Eyebrows, Tests Merck
Sales for Glaxos Cervarix amount to less than 10 percent of those garnered by Mercks similar vaccine. The comparison study may influence which vaccine doctors use and insurers pay for. It will be presented for the first time at a medical meeting in Malmoe, Sweden on May 10, according to a draft of the program obtained by Bloomberg News.
The study also will help governments determine which of the vaccines to select for immunizing women, influencing a global market that Glaxo estimated at more than $10 billion last year. Glaxos shot, used less often than Gardasil in Europe, hasnt won approval in the U.S., where Merck began selling its version three years ago.
Glaxos decision to wait 14 months to release the data and pick a little-known medical meeting as the venue “certainly has both my eyebrows up,” said Arthur Caplan, director of the University of Pennsylvanias Center for Bioethics, in Philadelphia.
“Half the world is waiting to see which vaccine is the better one,” Caplan said. “You have a huge ethical obligation to get information out quickly. Im never a fan of releasing key findings on a highly contentious issue, such as whos got the better vaccine, at a relatively unknown meeting.”
The study concluded in March 2008, according to its listing on the U.S. government database that tracks clinical trials.
Two Studies
Cervarix and Gardasil protect women against the sexually transmitted human papillomavirus. The virus can lead to cervical cancer, which kills 250,000 women each year.
Stephen Rea, a spokesman for Glaxo in London, said the company chose the International Papillomavirus conference in Malmoe because its “internationally renowned and has a reputation for scientific rigor.”
Glaxo also plans to release another key Cervarix study, known as HPV-008, which tracks the effect of the vaccine on more than 18,600 women, at the meeting. U.S. regulators will use the findings to determine whether to clear the shot later this year. The company wanted to present the two studies “as a package,” Rea said. “Attendees will be able to see presentations on the efficacy study and the head-to-head study” together, he said.
Glaxo needs Cervarix to help offset cheaper generics that eroded U.S. sales of four medicines last year. The London-based company reports first-quarter earnings later today. Profit fell in the fourth quarter.
Long Delay
Glaxos head-to-head study, dubbed HPV-010, measures which vaccine sparked a greater immune system response in more than 1,000 women seven months after the shot.
That means the results wont say which product works best to keep cancer at bay, though its the first indication of the bodys ability to defend itself, said Aaron S. Kesselheim, an expert in pharmaceutical epidemiology and economics at Harvard Medical School and Brigham and Womens Hospital in Boston. As such, it will help governments decide which product to pick, Caplan said.
“I cant explain the long delay,” Kesselheim said. “If you have positive results, wouldnt you want to get it out? If its negative, people should know that soon. Its concerning to me that the turnaround time for getting the data out there is so slow.”
Spitzer Settlement
Glaxo may have taken longer to analyze the research to see whether women were protected against other strains of the virus than the ones contained in the shot, according to Nick Turner, an analyst at Mirabaud Securities in London.
Glaxo has won exclusive contracts to provide Cervarix to young girls and women in the Netherlands and the U.K. since the study was completed. A spokesman at the U.K. Department of Health did not return calls seeking comment. Saskia Hommes, a spokeswoman for the Dutch Ministry of Health, said Cervarix was “cost effective.”
Glaxo, Europes fifth-largest drugmaker, has come under fire before for not promptly disclosing study results. When the company found that its Avandia diabetes medicine raised the risk of heart attacks in 2005, it submitted the findings to regulators and posted them on its Web site. It didnt notify doctors or patients.