FDA committee to consider Gardasil alternative for HPV

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A Food and Drug Administration advisory committee will meet Wednesday in Washington to consider possible approval of Cervarix, a vaccine against human papilloma virus (HPV) manufactured by GlaxoSmithKline Biologicals. The vaccine is designed to protect against two strains of HPV that account for 70% of cases of cervical cancer, and information in a briefing packageprepared for the meeting indicates that the vaccine is effective 93% of the time, about the same as Gardasil.

Although Cervarix is approved in Europe, its potential introduction to the U.S. in 2007 was delayed because of information suggesting that it might cause more cases of muscular and neurological problems than Gardasil. Subsequent research, however, has determined that Cervarix did not cause the problems.

Also Wednesday, the panel will consider an application from Merck to approve use of Gardasil in boys and young men. In addition to the two strains of cervical-cancer-causing HPVs covered by the vaccine, it protects against two other strains that are responsible for 90% of genital warts in males -- which Cervarix does not. The two strains have been linked to cancers of the penis and anus.

The Gardasil debate is expected to be vigorous. Critics of the vaccine have argued that its benefits in women do not justify the high price -- $400 for a three-dose series. They also note that it has not yet been determined how long protection against the HPV strains lasts. The cost/benefit ratio is even worse for men, they argue, because genital warts are generally self-limiting, and penile and anal cancers affect less than 1% of the population. Proponents, however, argue that vaccinating males would help protect females from contracting the sexually transmitted viruses.

The FDA is not obligated to follow recommendations from its advisory committees, but it generally does so.

-- Thomas H. Maugh II