HPV is rampant throughout the world, and the U.S. is no exception. It is estimated that up to 20 million people in the U.S. are currently infected with HPV -- men as well as women. It is not surprising, therefore, that Gardasil has burst onto the national stage as the latest 'wonder' vaccine. Manufactured by Merck, Gardasil is the first vaccine available that can prevent 4 strains of HPV, which is a leading cause of cervical cancer and pre-cancerous cervical conditions.
In nearly every state in the U.S. there is a legislative push to make the HPV vaccine mandatory for middle school aged girls, with catch-up clauses to cover girls that have passed that age but are not yet sexually active. Given the anxiety of most people about cancer and the number of people infected with HPV, it is not surprising that what is touted as the first vaccine against cancer has been largely greeted with acclaim. But despite having been affected personally, I became concerned by the headlong rush to not only approve the vaccine, but to mandate it for middle-school aged girls. It is also worrisome that a vaccine may give a false sense of security, which could lead to a decline in the very reliable and proven diagnostic tools available, including Pap tests. Decisions affecting millions of young women should not be made lightly, and certainly not without examining the marketing, PR, and profit motives of a corporation like Merck.
HPV and Cervical Cancer: Just the facts, Ma'am
According to the Centers for Disease Control and Prevention, as many as 50 percent of sexually active men and women become infected with Human Papillomavirus (HPV) at some point in their lives. Because the virus is so pervasive, by age 50, at least 80 percent of women will have acquired genital HPV infection. It is estimated that each year an additional 6.2 million Americans becomes infected by one of the strains of HPV. It is important to note, however, that only a few strains of HPV actually cause cervical cancer.
Despite how ubiquitous the virus is, basic knowledge about HPV and its link to cervical cancer is sadly lacking in the U.S. population. According to the 2005 National Cancer Institute's Health Information National Trends survey, only 38.3% of U.S. women surveyed said that they had heard of Human Papillomavirus or HPV. In addition, less than 50% thought that HPV caused cervical cancer.
HPV is significant not only because of the high infection rates among the population. HPV infection can affect fertility, can cause the sexually transmitted disease (STD) genital warts, and some strains can lead, in rare cases according to the Centers for Disease Control and Prevention, to cervical cancer. The CDC goes on to say that "Most people who become infected with HPV will not have any symptoms and will clear the infection on their own." That is to say, without any treatment, many infections are addressed by the body's own immune system. (The National Cancer Institute's survey noted that nearly 80% of women mistakenly believed that the body could not resolve the infection without treatment.)
For those whose bodies are unable to counter the infection without assistance, a Pap test provides a reliable method of detection, which, coupled with appropriate treatment, has drastically reduced the mortality rate of cervical cancer patients. The National Institutes of Health points out that HPV does not lead directly to cervical cancer but causes cell abnormalities, or dysplasia, which can over time develop into cancer. It is a slow progression, and "this pre-cancerous condition can be detected by a Pap smear and is 100% treatable." In addition, 92% of women are alive 5 years after a cervical cancer diagnosis if the cancer was kept from spreading outside of the cervical area.
So why is cervical cancer still an issue for women? In the developing world, lack of access to healthcare and routine tests like the Pap smear means that infections and early pre-cancerous conditions are not detected, and if and when women are diagnosed, it is with advanced, invasive cervical cancer that may have metastasized to other parts of the body. In addition, other cervical cancer risk factors, such as becoming sexually active at an early age and giving birth to several children, are more common for women in developing countries.
Globally, cervical cancer is the third most common type of cancer in women. It is much less common in the United States because of routine use of Pap smears for early detection, at least if you are white and economically privileged. In the U.S., tremendous racial and economic disparities exist in the general rates of cancer diagnosis, and cervical cancer is even worse than most. The Centers for Disease Control and Prevention have found that African American women still die from both cervical and breast cancer at much higher rates than white women. Perhaps due to cultural beliefs that talking about diseases can bring bad luck, Vietnamese women in the U.S. are 5 times more likely to develop cervical cancer than their white counterparts. Limited access to health care services and language and cultural barriers contribute to low rates of screening and treatment for other minority groups, such as Latinas, American Indian or Alaska Natives, Asian-American, and Pacific Islander women. This leads to later diagnosis and more invasive cancerous conditions that decrease the likelihood of survival for women in these groups.
Invasive cervical cancer is also more common in women middle aged and older, who are less likely to receive regular screening and early treatment, often due to lack of medical coverage, but also because of the misconception that it is a disease of younger women and that Pap tests are not as important as women age. Smoking also doubles the rate of cervical cancer. Not only do higher smoking rates correlate with lower levels of education and membership in a lower economic class, racial minorities have been consistently targeted by Big Tobacco marketing and so have had their cancer risk increased as well.
It can be informative to examine from what U.S. women are dying statistically. According to the American Heart Association, coronary heart disease, which causes heart attacks, is the leading cause of death for American women. "Many women believe that cancer is more of a threat, but they're wrong. Nearly twice as many women in the United States die of heart disease and stroke as from all forms of cancer, including breast cancer." Even so, a recent Washington Post article states that more than 200,000 US women are diagnosed with breast cancer each year and 40,000 die annually as a result -- a mortality rate almost ten times higher than that of cervical cancer.
None of this is meant to minimize the tragedy of cervical cancer, with which more than 11,000 U.S. women are diagnosed each year and which, according to the American Cancer Society, is expected to claim 3,700 lives in the U.S. in 2007 alone, and many times more in developing countries. It is instead meant to set the stage and to keep in perspective the risk as we examine the push for mandatory vaccination, especially since not all cases of cervical cancer are caused by HPV infection.
Enter Gardasil, the 'Wonder Drug'
Produced by pharmaceutical mega-corporation Merck, Gardasil is a vaccine given in a series of three injections before a girl has become sexually active to guard against HPV infection. Gardasil protects against four of the more than 30 strains of HPV - types 6, 11, 16, and 18. According to the Merck product site, "HPV Types 16 and 18 cause 70% of cervical cancer cases, and HPV Types 6 and 11 cause 90% of genital warts cases." Gardasil is the first vaccine approved by the U.S. Food and Drug Administration for prevention of HPV.
Gardasil is being touted as a "wonder drug" for women. Might it also be a wonder drug for Merck? In the world of drugs, vaccines for use by the whole population are close to corporate nirvana since they ensure a mass market for prevention instead of having to wait to identify the smaller number of people who actually develop a particular disease. In addition, mandating vaccination helps ensure a mass market and gets the government involved in what would otherwise be left to market forces.
The FDA's approval of Gardasil in June 2006, has allowed Merck to establish a substantial lead over its rival GlaxoSmithKline, which has an HPV vaccine, Cervarix, pending approval by the FDA. But by the time Cervarix is approved, which is expected to occur between October 2007 and January 2008, Gardasil will have enjoyed its monopoly status for between 16 and 19 months. Estimates of the global market value for HPV vaccines are that it will be worth $2 billion to $4 billion within three years.
Equally significant is that Merck is still recovering from the Vioxx scandal on 2005, in which Merck's prescription pain reliever was linked to an increase in heart attack risk. Worse still for the company was the assertion that Merck has intentionally kept secret findings of the risks associated with Vioxx while at the same time executing an aggressive direct-to-consumer advertising campaign to increase demand for the drug.
The Vioxx recall is estimated to have cost Merck $2.5 billion in annual revenue. According to Merck, As of March 31, 2007, Merck "has been named as a defendant in approximately 27,250 lawsuits, which include approximately 45,700 plaintiff groups alleging personal injuries resulting from the use of VIOXX, and in approximately 266 putative class actions alleging personal injuries and/or economic loss." In May 2007, Merck announced that it would be facing litigation in CA, AL, FL, NV, WV, TX, and IL state courts as well as in federal court in the folllowing nine months.
In March, 2007, MSNBC reported that Merck had a designated legal war chest of $1.64 billion for Vioxx legal costs, but had not set aside a penny for damages,intending to fight each case rather than settle out of court. As of September 2006, Merck had spent $325 million on defense costs during the first nine months of that year alone. MSNBC also reports that in New Jersey, a state Supreme Court panel is considering whether to uphold a lower court decision that would allow health insurers and union health plans to sue Merck jointly to recover money they paid for Vioxx prescriptions. Merck is appealing. If allowed to go forward, that lawsuit alone would potentially be worth more than $15 billion.
The Food and Drug Administration did not escape unscathed either. As the New York Times reported in December 2004,