Aug. 18, 2009

Is the HPV Vaccine Safe?

First Major Study Released on Vaccine's Side Effects, Plus a Review of Merck's Marketing Tactics

http://www.cbsnews.com/stories/2009/08/18/eveningnews/main5250640.shtml?tag=contentMain;contentBody

(CBS) When Barbara Archiello's doctor recommended a vaccine to prevent cancer of the cervix, she jumped at the chance.

"I think it's just a great thing for women to have," Archiello said.

But the most comprehensive look at the side-effects of since the HPV vaccine was approved in 2006 raises questions about its safety, reports CBS News medical correspondent Dr. Jon LaPook.

In Tuesday's Journal of the American Medical Association, the CDC reported more than 12,000 side effects after 23 million doses were distributed. Ninety-four percent of the problems were not serious but 6 percent were, including patients who were hospitalized, permanently disabled or died. There were 32 deaths - one in over 700,000 doses.

"It really isn't an increase with what we've seen with other vaccines and what is seen regularly with people of that age group," said Dr. Barbara Slade, with the CDC.

But problems that did occur more frequently than expected were fainting - about once every 12,000 doses, and blood clots, once every 500,000 doses.

"The reporting on blood clots was concerning to CDC, concerning in the way that we think it needs further investigation," Slade said.

Critics question the vaccine maker's aggressive ad campaign, because it paid medical societies to help spread the word, and underplayed the importance of evaluating the vaccine's risks and benefits.

"It screeched the message, 'all women are at equal risk, protect yourself from cervical cancer, and this is the way to do it,'" said Dr. Sheila Rothman, author of the JAMA article. "The fact that the medical societies repeated this message is what concerns us."

Merck says after reviewing the new report of adverse events, it continues to be confident in the safety of the vaccine. While the CDC and FDA continue to recommend its use, doctors say they'll look at the HPV vaccine for girls and women on a case-by-case basis.

"If you're going to administer the vaccine, you should discuss these risks with your patient and do a risk assessment." Said Dr. Daniel Smith, with Hackensack University's Medical School.

Something else to consider for parents uncertain about whether to have their daughters vaccinated - Routine pap smears can also help prevent cervical cancer.