MCG professor studies HPV vaccine
In late August, Katie Couric and Charlie Gibson warned Americans about the dangers of the Gardasil vaccine – but Georgian doctors are standing behind it 100 percent.
The news reports were sparked by a report by the Centers for Disease Control and Prevention published in the Aug. 20 edition of the Journal of the American Medical Association. Daron Ferris, a professor in the departments of family medicine, obstetrics and gynecology at the Medical College of Georgia, was one of the three reviewers of the report.
“The media didn’t properly interpret the findings of the CDC,” Ferris said in a telephone interview Aug. 28, adding the media “stirred up a hornet’s nest.”
Gardasil, manufactured by Merck, shown to reduce the risk of herpes and cervical cancer, is a three-dose vaccine to protect against the human papillomavirus.
“[The CDC] is strongly supportive of the vaccine,” Ferris said.
The report, he said, was not so much a formal study as it was a collection of Vaccine Adverse Events Reporting System reports. VAERS reports, he said, have neither control group nor placebo, and can be submitted by a range of sources including the manufacturer, the patient or a state health clinic.
The report looked at the 12,424 VAERS reports submitted between June 1, 2006, and Dec. 31, 2008 – an average of about 54 reports submitted per 100,000 doses of Gardasil. Out of these reports, 772 serious reactions were reported, 32 of which were death, according to the CDC report.
The report said serious events occurring after patients received the vaccine included pancreatitis, convulsion and anaphylactic reactions among others. It cautions, however, in some instances, improper reaction coding was recorded and reported to VAERS.
“Our review of 12,424 reports of [adverse reactions] following receipt of [Gardasil] after licensure found that most did not meet the [Food and Drug Administration] definition of serious,” the report stated. “Reported deaths with available records, autopsy reports or death certificates describe causes other than recent vaccination.”
Ferris said he has not seen anything to worry him about the use of Gardasil.
He is so confident in the safety of Gardasil that he is studying how it compares to a new vaccine, also produced by Merck, referred to as Gardasil “Plus.”
“This is a very exciting study,” he said. “We’re going to see how much better the new vaccine is and make sure it’s equally as safe.”
Female University students are involved in the study. After being screened to make sure they are able to participate, they will either receive the three-dose injection of Gardasil or Gardasil “Plus.” None of the women will receive a placebo, which Ferris said is what makes this study unusual.
Lynn Allmond, a nurse practitioner working with Ferris, is the person to see most of the patients.
She said they chose to work with the University because of its large female population in the target age group for the vaccine.
Most of the side effects she has seen with the vaccine are related to the injection site, she said. Other effects include fever, fatigue and upset stomach.
“They’re reported because we’re required to report it, but they may or may not be related to the drug,” she said in a telephone interview Tuesday.
Gardasil prevents several types of HPV, including those that cause penile, cervical, anal and throat cancer, as well as HPV strains causing genital warts, Ferris said.
Gardasil “Plus,” on the other hand, is a “9-valent” vaccine that will expand the protection against HPV to nine types, seven of which have been linked to cancer.
Ferris said 80 percent of people will get some form of HPV in their lifetime.
He said HPV, a sexually transmitted disease, causes cancer by preventing damaged cells from killing themselves, a process known as “apoptosis” – or programmed cell death – causing tumors to form.
“If it gets to the point where [HPV] cannot fix a gene, it immortalizes the cell,” he said. “Cervical cancer-if you can imagine sitting on a hand grenade, that’s what it does to you.”
In addition to saving at least $360 by getting the vaccine for free, study participants will receive free pap smears and lab tests, Ferris said.
They will also earn $75 per visit for their participation over the next three and a half years.
Ferris advises all females between the ages of 16 and 26 to get Gardasil, or Gardasil “Plus,” which he said will be on the market within five years.
“It’s a miracle vaccine; the first vaccine to prevent cancer, and that’s a blessing,” he said. “It’s just phenomenal.”



