FDA panel backs Gardasil (HPV vaccine) safety and efficacy for genital warts in young men

News outlets are reporting that an FDA advisory panel “endorsed the use of” Merck’s Gardasil “for boys and young men.” The panel “voted in favor of the safety and efficacy of” the vaccine “to inhibit genital warts in boys and men ages nine to 26,” the New York Times noted. The vaccine is already “approved … to protect girls and women ages nine to 26 against certain strains of” human papillomavirus (HPV).

In a post on its “Booster Shots” blog, the Los Angeles Times noted that the vaccine “protects against two strains of HPV that are associated with 70 percent of cervical strains,” as well as two “strains that are associated with 90 percent of genital warts, which are sometimes precursors of anal and penile cancer.”

In addition, it has been reported approximately one-half of penile cancers are associated with the Human Papilloma Virus (HPV) and it has been suggested that the virus may be associated with prostate cancer.

The Dow Jones Newswire reported, “Specifically, the panel of outside medical experts voted 7 to 0 in favor of a question that asked if the data submitted by Merck showed whether Gardasil was effective at preventing genital warts” in young men. “One person abstained from voting.”

With regard to safety of the vaccine, “the panel voted 7 to 1 in favor of [a] question that asked if the data showed whether the vaccine was safe.”

According to a Bloomberg News story, “US officials have received 12,424 reports of side effects with Gardasil, about 54 reports for every 100,000 vaccine doses distributed,” a special communication in the Journal of the American Medical Association reported. The panel’s consumer representative “voted against the safety” of Gardasil, “citing lack of long-term proof that” the vaccine is safe.

And, the nay vote was not without good reason. JAMA asks in an editorial whether any level of risk is appropriate in the case of HPV vaccination. “I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” the editorial’s author, Dr. Charlotte Haug, told the Times.

Dr. Harper, who helped test Gardasil, says that “data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.”

The proclamation “raises questions about the recommendation that the series of shots be given to boys as young as 9-years old.

If we vaccinate 9 year olds and the protection doesn’t last … we’ve put them at harm from side effects, small but real, for no longterm benefit.

And another JAMA study dropped a bombshell: Merck gave money to three medical societies to fund their promotion of Gardasil.

Researchers from Columbia University said the American College Health Association, the American Society for Colposcopy and Cervical Pathology, and the Society of Gynecologic Oncologists used Merck funding on educational materials and lectures that offered lopsided information about the vaccine’s risks and benefits.

“I think what happened here was that marketing and medical education got blurred,” co-author Sheila Rothman told the Washington Post. “This shows how [Merck was] able to influence physicians,” Diane Harper of the University of Missouri, who helped test the vaccine, told the paper.

CNN reports that the panel’s decision was based on “data from three clinical trials” of over 5,400 boys and men “that the company claims supports broadening the distribution of the vaccine to include males.”

A spokesman for the American Social Health Association noted that the trials showed that the vaccine is “90 percent effective in preventing genital lesions [in boys],” HealthDay reported.

So, at this point, given that we don’t know how long the protection will last, given that it’s a very expensive vaccine, and given the concerns about side effects (at least in the girls who have had the vaccine), color me cautious on this one.

You can read my previous posts about Gardasil:

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