At the April 9, Public Oversight Hearing, Committee on Health
Proposed Fiscal Year 2010 Budget for the Department of Health
I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies, and to compare their safety and effectiveness.
I was trained in epidemiology at Yale Medical School. I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for 25 years. In addition, I am a fellow at the University of Pennsylvania Center for Bioethics.
Like all of you, I am interested in the health and safety of D.C.’s citizens, and like many of you I was, until recently, strongly in favor of mandating the HPV vaccine for girls. Who among us wouldn’t gladly immunize our daughters to protect them from cervical cancer?
I am here today to share with you some research information that I have only recently uncovered and draw attention to a number of unanswered questions regarding Gardasil, the only HPV vaccine currently available in the U.S. This research information is available on the FDA web site but most of it is not published yet.
As most of you know, Gardasil protects against two types of Humanpapilloma Viruses (HPV) that cause genital warts and two types of HPV that cause cervical cancer. Almost all HPV viruses go away by themselves – just like a cold virus goes away by itself. The goal of the vaccine is to protect the less than 10% of girls and women for whom HPV does not go away by itself.
In clinical trials, Gardasil has been shown to be 100% effective against those 4 HPVs – but not for very long. The FDA approved Gardasil based on about 2-3 years of data! Even Merck, the vaccine’s manufacturer admits that, “the duration of protection of Gardasil has not been established.” All that we know now is that it stimulates short-term protection against various strains of HPV and certain kinds of lesions known to be precursors of cervical cancer.
There is new evidence that if Gardasil is given to 12 year old girls, they will not be well protected when they are 16 or 17:
1. Just three years after being vaccinated with Gardasil, one-third of the girls had lost all their antibodies to one of the two strains of HPV that can lead to cervical cancer-HPV 18. Girls with antibodies to HPV are protected against HPV. Those without probably aren’t.
2. Older teenagers who were already exposed to HPV but didn’t have active infections when vaccinated benefited as much as 12 year olds
3. Teenage girls and young women who were exposed to HPV through sexual contact had as many or more antibodies against HPV as those who were vaccinated. Since not all girls are exposed to HPV and about 90% of HPV infections go away by themselves without any risk of cancer, the vaccine is providing protection to less than 10% of all vaccinated girls.
4. In their studies, Merck gave a booster shot to all the girls and young women 5 years after they were vaccinated with Gardasil. Then they measured their antibodies and reported how high they were after 5 years – but they don’t sell anything called booster shots for HPV and they have never advertised or publicly discussed the need for a booster shot.
5. Gardasil is the most expensive vaccine in the world, consisting of 3 shots that cost between $400 and $1,000. The booster shot in the Merck study was a repeat of the first Gardasil shot and costs at least $150.
When the Centers for Disease Control and Prevention recommended Gardasil for young girls, they didn’t have all this research information. They assumed the vaccine would last forever, not for just a few years. They believed Merck – as we all did – that it was important to vaccinate young girls before they were sexually active. But that doesn’t seem to be true.
Instead, if we vaccinate 12 year old girls, we will probably have to vaccinate them with a booster shot when they are 16 or 17. In fact, they might need another booster shot every 5 years for the rest of their lives.
Most women in Washington are unlikely to be able to afford those expensive HPV booster shots every 5 years. If they don’t get them, however, they will no longer be protected from cervical cancer at an age when they are most likely to get it.
What can we do about this? The good news is that there is another HPV vaccine that has been shown to last longer – more than 6 years. It is already approved in 66 other countries. However, it is still being analyzed by the FDA so we don’t yet know if it is really that effective.
The other good news is that if the DC government decides to delay any kind of HPV vaccine program for a year, that will not harm our girls. The reason it won’t harm them is that Gardasil seems to work even better if it is given to older girls and young women, instead of 12-year olds.
So, as a budget matter, I strongly urge you to delay implementing an HPV vaccine program for another year, until data are available to tell you which HPV vaccine is more effective and more cost effective.