Personal Injury Law

Gardasil Subject of Back-To-School Campaign

By Jane Akre

Back To School

Drugmaker, Merck & Co. is planning a big back-to-school push for Gardasil, the controversial humanpapillomavirus vaccine targeted at young teen girls.

Merck is ramping up ad spending, reports Fierce Pharma and expect to see those ads in doctors' offices, clinics, and in direct-mail.

"Resources were made available several months ago to support execution during the back-to-school time frame," a Merck spokeswoman told AdAge.

Federal health officials recommend girls, ages 11 and 12, receive Gardasil to protect against cervical cancer, the second most common cancer in women worldwide. The FDA reports 12,000 women are diagnosed in the U.S. every year and 4,000 will die from the disease.

But increasingly parents and doctors are just saying no. CNN reports on Raffi Darrow, of St. Petersburg, Florida, who declined the shot for her two daughters.

"Up until now my children have had every vaccine doctors have recommended," says Darrow, a graphic designer in St. Petersburg, Florida. "But most friends, like me, fear the safety of something new."

And a survey of more than 1,100 physicians in Texas showed about half don't always recommend Gardasil to their young patients.

Gardasil sales have been slightly disappointing with second-quarter sales down 28 percent from last year, but amounting to $268 million.

In June 2008, drug maker Merck was denied approval by the Food and Drug Administration (FDA) for expanding the recommended age range for the vaccine from the 13-to-18 group to the 19-to-26 age group.

A published study from Harvard said it did not appear to be cost-effective, because older women may have already been exposed to the humanpapillomavirus.

A Harvard study found vaccinating boys with the HPV shot may be less cost-effective than girls.

Merck counters that the HPV vaccine for boys and young men up to the age of 26, may cut down on cancers of the anus and penis, and reduce reinfection to women.

The Centers for Disease Control and Prevention (CDC) will vote in the fall whether to recommend the shot for boys.

Background

Gardasil was approved in June 2006 for use in young females who have not yet been exposed to the HPV strains (types 6, 11, 16 and 18), two of which cause genital warts and two that cause about 70 percent of cervical cancers.

Most women, about 80 percent, are infected with HPV, which goes away on its own the majority of the time. Gardasil does not address a current HPV virus.

Merck launched an aggressive "Just One" campaign to persuade mothers to have their children inoculated, but the drug is not without controversy.

A study of Gardasil by the National Vaccine Information Center (NVIC.org), found more than 80 reports of adverse reactions including seizures, passing out, and Guillain-Barre syndrome. After that, the FDA required a more prominent warning about the potential for some young teens to experience jerking movements and seizures after being inoculated.

As of May 1, there were 13,758 reports of adverse events linked to Gardasil, among the more than 24 million doses given.

At least 39 deaths have been linked to the Gardasil vaccine, though the CDC will not confirm they were caused by the vaccine. Despite that, the CDC has not changed its recommendations for the use of Gardasil.

The National Vaccine Information Center has alleged that the FDA and Merck fast-tracked Gardasil's licensure with flawed science.

And the doctor who helped Merck do clinical trials on Gardasil, Dr. Diane Harper, an obstetrician and gynecologist at the University of Missouri, has concerns about the HPV vaccine for pre-adolescents.

She tells CNN, "Gardasil is not without risks. It's not a freebie." She is concerned that during clinical trials, 1,121 young girls between 9 and 15 were inoculated, not enough to prove safety. The efficacy of the drug over time is also not certain.

The FDA and Centers for Disease Control and Prevention are monitoring the safety of vaccines through the VAERS system.

Many doctors are advising against having a young woman vaccinated until the drug has been on the market for five years and any adverse effects are seen.

A research paper by the Guttmacher Institute, a nonprofit that focuses on sexual and reproductive health, says that HPV is spread through skin to skin contact, not through bodily fluids, so a condom would be effective in stopping its spread.

Competitor, GlaxoSmithKline PLC's Cervarix, is the HPV vaccine of choice in Great Britain and may be approved in the U.S. soon. It has been tested in older women. #

Full post as published by InjuryBoard on August 18, 2009 (boomark / email).