The term "sexually transmitted disease" is charged with emotion. The effects of STDs range from gross, like the draining sores of herpes simplex, to lethal, such as AIDS from HIV. For most STDs there is treatment but no cure or prevention. Recently, a vaccine was found that prevents a potentially lethal STD—human papilloma virus. But the HPV vaccine, which has the potential to save hundreds of thousands of lives, has run into serious political and legal roadblocks.
HPV is an STD nearly endemic in our society, the low estimates being tens of millions of affected Americans. As one medical school professor once described it to our class during a lecture on STDs: "If you have ever had unprotected sex with a partner who has had unprotected sex with anyone else, you have been exposed to HPV." Because a person can be infected but show no symptoms it is easily passed from partner to partner. Also, it can take weeks to months for symptoms to appear. To further complicate the issue, HPV has multiple strains, each of which has a different effect. To date, more than 100 strains have been identified, with more than 30 of the strains being sexually transmitted. Some of them are cleared from the body without any symptoms ever presenting, others cause genital warts, and some cause cancer. By age 50, according to the Centers for Disease Control estimates, at least 80% of women will have acquired genital HPV infection.
While HPV can lead to several types of cancer in men or women, including cancer of the penis, vaginal area or anus, the concern about HPV has always focused on cervical cancer, because it is a silent killer, typically without symptoms until it is at a very late stage and too late to do anything about it. Until the development of a vaccine, prevention of cervical cancer has relied entirely on women getting regular pap smears, which can detect changes in the cervix, leading to early treatment. In 2004, according to the American Cancer Society, over 10,000 women contracted cervical cancer and nearly 4,000 women died of it. Almost all of the deaths occurred in women who had not had regular pap smears.
In 2006 the FDA approved Gardasil, an HPV vaccine targetting four HPV strains that together account for 70% of the cervical cancer and 90% of the genital warts caused by HPV. This was a huge leap forward in the fight against cervical cancer. It is recommended by the FDA for women age 9 to 26 who have never been exposed to HPV, with immunity provided for close to five years. But even before it appeared on the market it met with strong opposition. Among the first to fire preemptive sorties against the vaccine was Concerned Women of America – a right-wing Christian Conservative organization that seeks to “bring Bible principles into all levels of public policy.” Prior to the vaccine’s FDA approval, CWA Executive Vice President Wendy Wright said her organization was against immunizing preteens against HPV. “It would seem to send a message that we’re expecting the girls to be sexually active,” she said. The ferociously conservative Family Research Council, initially vocal in its opposition to the vaccine, has softened its tone, if only a little. FRC Vice President for Policy Peter Sprigg, in a July 15, 2006 opinion piece for WashingtonPost.com, shied away from opposing the vaccine outright, but opposed states making it a mandatory vaccine. In other words, the great defender of states’ rights while the Democrats held the presidency now wants to take power away from the states, so that the vaccine will remain out of the public eye and most girls won’t be immunized.
But even with FDA approval and CDC support, the HPV vaccine has slammed into another wall: cost. Merck, the company that owns Gardasil, charges $120 per dose, with three doses required to provide immunity. But insurers are barely willing to pay for each dose, much less the costs of administering it. CNN.com reports in a Feb. 2, 2007 article that doctors are expected to stock thousands of dollars in inventory, store the vaccine in highly specialized refrigerators, pay for any broken or damaged vials at $120 each, provide syringes, administer the vaccine and pay for disposal of the sharps all for as little as $2 over the cost of each dose administered. Thus, being forced to lose money by providing the vaccine, many pediatricians and family practitioners have stopped providing it. With the public spotlight on the vaccine, some insurers have relented and are raising their reimbursement. But for those without insurance, or insurance that doesn’t provide coverage, or only partial coverage, the vaccine remains out of reach.
There’s an old saying in the pharmaceuticals business: The first pill costs you half a billion dollars, everything after that is profit. Merck says that it will provide the vaccine for free to those who can’t afford it, but the big drug companies say this about all their expensive products, and as any patient who has tried to apply for such fee waivers or any physician who has tried to help their patients apply for the waivers can tell you, cutting through the red tape involved in actually getting a waiver requires a bulldozer. In fact, Merck gave away only about 800 doses in the last three months of 2006. To have an idea of how expensive $120 per vaccine is, consider the following CDC list of vaccine costs, per dose, in 2007: Diptheria/Tetanus/Pertussis: $12.25; Hepatitis B: $26.25; Hepatitis A: $35.57; Mumps/Measles/Rubella: $17.28; Varicella (chickenpox): $56.90.
It is expected that the overall cost will decline over time, but given the prevalence of HPV, the high cost of the vaccine, the reluctance of the insurance industry to pay that cost, vocal opposition from politically connected right wing organizations who think money is better spent telling youngsters to wait until marriage, and tepid support from a presidential administration that sees eye to eye with the Conservative Christians, it is likely that cervical cancer will continue to be a killer for a long time. For parents who would like their daughters immunized and young women who would like to be immunized against HPV, and thus drastically reduce their chances of contracting cervical cancer, the struggle continues.Powered by Sidelines