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Gardasil Studies Look at Allergic Reactions, Moms’ Attitudes

Australian researchers are reporting that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.

Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, nausea, and rashes. Researchers at The Children’s Hospital at Westmead studied 114,000 young women vaccinated with Gardasil as part of a 2007 vaccination program in New South Wales. Of the girls vaccinated, 12 experienced suspected cases of anaphylaxis. Eight of the 12 experienced “an estimated rate of reaction of 2.6 per 100,000 doses administered” as compared with “a rate of 0.1 per 100,000 doses in a 2003 school-based meningitis vaccination program.”

Another Gardasil study - this one conducted at the University of Texas Medical Branch (UTMB) at Galveston - has found that most moms who choose not to get their daughters vaccinated for HPV are not simply sexual prudes. Since Gardasil came on the market, opponents of vaccination are often portrayed as social conservatives whose biggest concern is that girls will become sexually active too soon if they receive it. But according to this new research, mothers’ objections mostly center around the safety and effectiveness of Gardasil.

The study, published in the September Journal of Adolescent Health, surveyed about 150 mothers at a UTMB pediatric clinic in 2007. The study found that mothers who wanted their daughters to remain virgins until marriage were just as likely to have them get Gardasil as those who didn’t expect their daughters to wait until marriage to have sex.

The study’s lead author, Susan Rosenthal, a UTMB pediatric psychologist, said that “Mothers who haven’t had their daughter vaccinated yet most often said they want more time to learn about the vaccine.”

What is Gardasil Worth?

The cost effectiveness of Gardasil is being questioned by an article in the New England Journal of Medicine. The article details an analysis conducted by Harvard researchers that found that cervical cancer vaccines are only cost effective if used in certain ways.

The three-shot Gardasil series can cost as much as $1000 to complete, and unlike other vaccines, it doesn’t usually save health systems money. That’s because, in Western countries like the U.S., regular Pap tests have already done a lot to prevent cervical cancer. Gardasil doesn’t reduce or eliminate the need for Pap tests, though, because it doesn’t protect against all strains of HPV that cause the disease.

The Harvard researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. They predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That’s because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.

But what if immunity doesn’t last a lifetime? That’s areal possibility because Gardasil hasn’t been around long enough to know how long its protection lasts. If the vaccine’s protection against HPV stops after 10 years, the cost of vaccinating preteen girls would more than triple to $144,100 per year of life gained, the study said. In those case, the researchers said that cervical cancer prevention through Pap testing alone would make more sense from a cost standpoint.

Article Sheds Light on Gardasil Approval, Marketing

An article in today’s New York Times gives some interesting details on Gardasil’s approval, and Merck’s marketing of the vaccine, as well as critics’ objections to both. Just some quick highlights:

• The Food & Drug Administration (FDA) expedited Gardasil’s approval application, and gave it the ok in just six months. It was recommended by the Centers for Disease Control (CDC) for girls ages 11-12 just weeks later. Dr. Diane Harper, a researcher who worked on Gardasil clinical trials, and who has been mentioned on this blog before, says that was too fast. She said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance. “In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”
• In clinical trials, there were indications that immunity from Gardasil might start to wear off after just five years. That means that a girl who had the vaccine at age 11 might not have any protection when she reaches college.
• In Western countries, like the U.S., cervical cancer is already preventable via regular Pap tests, but Merck’ Gardasil marketing has created a panic about the disease. And because Gardasil doesn’t work against all forms of HPV, regular Pap tests are still needed.
• In addition to its “one less” commercial, Merck has paid hundreds of doctors to lecture and give talks on Gardasil. The Times says some doctors are getting paid $4500 per lecture.
• Merck has also been lobbying politicians, state officials and others to convince them to pass legislation to fight a global killer - which pretty much translates into making Gardasil mandatory for young girls.
• Merck’s efforts are working. According to The New York Times, Gardasil has now been made available to the poorest girls in the country, up to age 18, at a potential cost to the U.S. government of more than $1 billion. Proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.

Possible Gardasil Side Effect: Pancreatitis

Australia’s Therapeutic Goods Administration (TGA) is investigating three cases of pancreatitis that might be linked to Gardasil. According to the TGA, 3.7 million doses of Gardasil, have already been distributed in Australia and to date there have been about 1,013 reported adverse reactions. These have included soreness, swelling, redness or other reaction at the injection site, headaches, dizziness, nausea and vomiting.

However, some of the side effect reports have been for serious ailments. Among the most serious are three cases of pancreatitis. Pancreatitis occurs when pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. This causes a sudden, debilitating attack of severe upper abdominal pain. Complications include respiratory, kidney or heart failure, all of which can be fatal.

One of the Australian pancreatitis cases was recently discussed in an article in the Medical Journal Of Australia. According to that article, a 26-year-old woman was admitted to the hospital four days after receiving her first dose of Gardasil. She was hospitalized for 10 days with fever, rash, severe pain and vomiting and was diagnosed with pancreatitis.

The doctors treating her could not find a cause for the pancreatitis, and wrote in the article that the Gardasil vaccine could not “be excluded as a potential cause”. They also wrote that pancreatitis should “be considered in cases of abdominal pain following HPV vaccination.”

How Realistic Are Merck’s Gardasil Claims?

Merck has been pushing Gardasil by claiming it could prevent 70 percent of all cervical cancers. But according to two experts - one of whom actually worked on developing Gardasil - there is no way to know right now how effective Gardasil is going to be in the long run.

“If we vaccinate every single 12-year-old, it should reduce by half the number of cervical cancers in the next 35 years,” Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, said in an article published in the Sun-Sentinal. “With Pap screening, we’ve reduced it by nearly 75%.”

People who have been following the Gardasil controversy might recognize Dr. Harper’s name. Not only was she a lead researcher on Gardasil clinical trials, but a few months ago, she actually criticized Merck’s efforts to convince states to make Gardasil a mandatory vaccine for young girls.

Another expert, Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine, said in the same Sun-Sentinal article that tests of Gardasil before the FDA approved it didn’t run long enough to prove its effectiveness conclusively - especially since it can take a decade for someone exposed to HPV to develop the cancer.

“Even though it guards against two HPV strains, the other HPV types need to be taken into account,” Dr. Smith-McCune said. “It will take a long time before we know the true efficacy of the vaccine.”