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Part One: Setting the Stage

by JUDITH SIERS-POISSON

Many women, myself included, have been affected by cervical cancer or Human Papillomavirus (HPV) at some point in their lives. In this series of four articles, I will examine HPV and Gardasil — the facts, the hype, and what Merck stands to gain; the marketing campaigns promoting Gardasil in the U.S. and the media’s lack of attention to concerns about the rush to mandate vaccination; the role of the non-profit group Women In Government in promoting mandatory vaccination against HPV; and what is going on outside of the U.S. on this issue.

HPV is rampant throughout the world, and the U.S. is no exception. It is estimated [1] 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 [2] has burst onto the national stage as the latest ‘wonder’ vaccine. Manufactured by Merck [3], 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 [4], 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 [5]’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 [6].

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 [7], 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 [8].)

Pap smears can detect early pre-cancerous conditions and have drastically improved survival rates. For those whose bodies are unable to counter the infection without assistance, a Pap test [9] 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 [10] 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 [11] 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 [12], 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 [13] 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 [14], 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 [15], Gardasil [16] 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 [17], “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 [18] 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 [20], 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 [21] 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 [22] 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 [23] 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 [24], 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 [25] 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 [26] did not escape unscathed either. As the New York Times reported [27] in December 2004,

“The Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx’s dangers would take four more years. … As a result of the agency’s shifting its resources, almost everyone, including critics, outside drug safety experts, medical journal editors, some industry executives and even top agency officials, now agrees that its mechanisms for uncovering the dangers of drugs after they have been approved are woefully inadequate.”

Merck is pushing hard for a drug that in their ideal world would be given to every middle-school aged girl and would be mandated by each state. The FDA is assuring us that this drug is safe and effective for mass vaccination of young girls. With their combined track record, shouldn’t we be concerned?
Access in Theory, and in Practice

Momentarily setting aside valid concerns about the mandating of a new vaccine, there are other issues to consider. Gardasil is not an inexpensive drug. Each vaccine shot will cost $120 through private insurance, or $96 through governmental programs buying at the federal rate. Those that have insurance may only need to pay a co-payment if it is offered by their provider and those on government assistance programs might not pay at all, but those without insurance would have a hefty bill to pay, particularly if it is mandated for school attendance, and if there are several girls in a family. $360 on average for each girl would add up quickly for a family that may fall in the working poor class — the people that most often do not have health care through their employer but do not qualify for government assistance. These are the same women that are most likely not receiving regular Pap tests to detect early pre-cancerous conditions before they develop into life-threatening cancer.

The idea of mandating HPV vaccination for girls as a requisite for school attendance may seem helpful, or at worst benign, but this isn’t the case. Government mandates often create requirements, but not the funding to fulfill them. Even a government recommendation can have far reaching effects on access. On June 8, 2006, the U.S. Food and Drug Administration [28] approved Gardasil as the first vaccine against Human Papillomavirus (HPV). Less than a month later, the Advisory Committee of Immunization Practices (ACIP) unanimously recommended vaccination for 11 and 12 year old girls. According to the Oncology Nursing Society [29], the ACIP also “resolved that the HPV vaccine be included in the Vaccination for Children (VFC) Program, a national effort that provides free immunizations to children who are Medicaid eligible, uninsured, underinsured, or Native American. ‘About 40%­45% of the U.S. child population is included in the VFC,’ said Lance Rodewald, MD, of the Immunization Services Division.'”

This may sound positive, but Dr. Diane Harper sees it differently. Dr. Harper is a Professor at the Dartmouth Medical School and has been studying HPV for almost 20 years. She was involved with both Merck and GlaxoSmithKline in HPV vaccine trial design and served as a principal investigator at the clinic site for both the phase two and phase three trials for Gardasil and Cervarix.

In our interview, she stated that this federal directive to provide the vaccine free to such a large segment of the U.S. child population falls to the states, and federal funding covers at best 10% of the cost of the program. So the federal government is requiring states to cover the children, and the states themselves might choose to make the vaccine mandatory for school attendance. But 90% of the children who would in theory receive the shots free won’t, and so parents will have to pay for the shots out of pocket or risk their daughter being barred from going to school. And those children that are covered by private insurance? Dr. Harper explained further that particularly with a drug as expensive as Gardasil, its inclusion in the Vaccination for Children program provides insurance companies with a perfect reason not to cover the shots for anyone under 18 years old beginning July 1, 2007.

“Insurance companies are saying that VFC program is required by law to purchase this. But the problem is that the states don’t have enough money allocated by VFC to purchase enough to cover their whole state’s population. So if you make a mandate that your child can’t enter sixth grade as a twelve-year old without having the shots, and your state only has enough to give it to 10% of the twelve-year olds, and you’re the next kid in line and your family doesn’t have $500, then you can’t go to school. And that is wrong.”

According to the National Center for Children in Poverty [30] at Columbia University, 18% of children in the U.S. live below the federal poverty level ($20,650 a year for a family of four) and 38% of children live in low-income families. There is obviously a huge gap in coverage for those who can’t afford the shots on their own. For most families, said Harper, “it would be an onerous amount to pay. And it would be awful to link your further education with your inability to pay for a vaccine.”

Merck used its deep pockets to make sure that even before the FDA had approved Gardasil, there was a growing awareness of and concern about HPV and its link to cervical cancer. According to Bloomberg News [31], Merck spent $841,000 for Internet ads alone relating to HPV in the first quarter of 2006 — months before the FDA had even approved Gardasil.

In the next article, “Research, Develop, and Sell, Sell, Sell,” we’ll look in detail at the extensive marketing campaigns in the US which were in place before FDA approval and what has happened since.

JUDITH SIERS-POISSON is association director of the Center for Media and Democracy. She can be reached at: judith@prwatch.org

Links:
[1] http://www.cdc.gov/std/HPV/STDFact-HPV.htm#common
[2] http://www.sourcewatch.org/index.php?title=Gardasil
[3] http://www.sourcewatch.org/index.php?title=Merck
[4] http://www.cdc.gov/std/HPV/STDFact-HPV.htm#common
[5] http://www.sourcewatch.org/index.php?title=National_Cancer_Institute
[6] http://hints.cancer.gov/questions/
[7] http://www.cdc.gov/std/HPV/STDFact-HPV.htm#cancer
[8] http://hints.cancer.gov/questions/
[9] http://en.wikipedia.org/wiki/Pap_test
[10] http://www.nlm.nih.gov/medlineplus/
[11] http://www.cdc.gov/omh/AMH/factsheets/cancer.htm
[12] http://www.americanheart.org/presenter.jhtml?identifier=4786
[13] http://www.washingtonpost.com/wp-dyn/content/article/l
[14] http://www.cancer.org/docroot/CRI/content/
[15] http://www.sourcewatch.org/index.php?title=Merck
[16] http://www.sourcewatch.org/index.php?title=Gardasil
[17] http://www.gardasil.com/
[18] http://www.sourcewatch.org/
[19] http://bendib.com
[20] http://www.sourcewatch.org/index.php?title=GlaxoSmithKline
[21] http://www.philly.com/inquirer/business/
[22] http://www.sourcewatch.org/index.php?title=Merck
[23] http://www.sourcewatch.org/
[24] http://www.merck.com/newsroom/
[25] http://www.msnbc.msn.com/id/17814905/page/2/
[26] http://www.sourcewatch.org/
[27] http://www.nytimes.com/
[28] http://www.sourcewatch.org/
[29] http://www.ons.org/publications/journals/
[30] http://www.nccp.org/topics/childpoverty.html
[31] http://www.bloomberg.com/apps/

 

 

 

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