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The HPV Vaccine: Good Science or Bad Politics?

Six years ago, I quit my job and embarked on a six-month tour of Asia. Knowing I would face mosquitoes, funky water, and suspicious street food, I consulted a travel doctor to find out what medications and vaccinations I needed. Some vaccines she deemed mandatory—typhoid, tetanus booster, hepatitis A—and some, like hepatitis B, she strongly recommended. You can contract the hepatitis B virus when the blood of an infected person enters your body; unprotected sex and intravenous drug use are common routes of transmission. I was not planning to do any of these on my trip, but I got the vaccine anyway. Chronic hepatitis B infection can cause liver cancer and cirrhosis, neither of which sounded very pleasant.

Nowadays, children are routinely given the hepatitis B vaccine as infants (it became widely available in 1982). This is not surprising, except that the introduction of a very similar vaccine—the one to protect against human papillomavirus (HPV)—has caused a political and social uproar. The controversy is perplexing, given the similarities between the two viruses. Just as hepatitis B causes liver cancer, HPV causes cervical cancer. Both viruses require intimate contact for transmission, and HPV is even more prevalent (see, HPV: Stirrups or Chastity?). If we already vaccinate against a virus like hepatitis B, why weren’t we prepared to do so for HPV?

“With hepatitis B, there was no mass marketing, so it was quietly discussed with parents and physicians in doctor’s offices,” said Lynn Hanson, a nurse practitioner and HPV researcher at UCSF’s Dysplasia Clinic.

“I think Merck [the maker of the HPV vaccine] sabotaged itself because it came out with such a strong, aggressive marketing campaign, so it became a hot topic in the news and was put on the political agenda.”

She also notes that GlaxoSmithKline has developed another HPV vaccine, which is expected to get FDA approval this year. It is no surprise, therefore, that Merck made a huge push to make their vaccine, Gardasil, mandatory before facing competition. Costing about $360 for a three shot series, the vaccine would have generated billions of dollars if required for every school-aged girl.

It is disturbing, though not surprising, that a pharmaceutical company helped distort a public health discussion that should have been decided by scientists, physicians, and parents. While the Centers for Disease Control and Prevention (CDC) recommends Gardasil for girls aged eleven through twenty-six, they did not go so far as to make the shots mandatory. Merck’s tactical lobbying campaign, aided by Women in Government, a group of state legislators that has received funding from both Merck and Glaxo, opened a Pandora’s box of doubts, concerns, and criticism regarding the vaccine.

I was curious to hear what D.A. Henderson, Professor Emeritus at John Hopkins School of Public Health, had to say about the call for mandatory vaccination. In 1967, Dr. Henderson led the World Health Organization’s global smallpox eradication program, and is a renowned expert on immunization. While he believes HPV is an “excellent” vaccine that all teenagers should get, he cautions against compulsory policies.

“There is a tendency to want to add important vaccines to a mandated list and the intention is laudatory. However, I do not believe that the public in most areas will accept this approach vis-à-vis HPV. Indeed, my concern is that there might be a backlash such that it might discredit a valuable preventive tool.” 

The backlash has certainly materialized, though different groups are coming at the issue from different angles. The religious right is protesting vaccination against an STD, based on the assumption that it will lead to promiscuity (a position that is hard to defend, since the vaccine does not immunize against other STD’s or unwanted pregnancy). Some are worried about mass vaccinations without complete knowledge of side effects. Others are simply wary of a vaccine being used to generate corporate profits. Texas was one of the first states to mandate the vaccine, but this decision was questioned when it was revealed that the Governor’s former chief of staff is a lobbyist for Merck.

Regardless of how one feels about the vaccine, there is little debate over its utility and significance. Clinical trials show that Gardasil is highly effective in preventing infection with the HPV strains that cause cervical cancer and genital warts. HPV is also associated with vulvar, anal, and penile cancers, so the vaccine may be effective in preventing these rare but serious diseases.

Although regular pap smears and preventive treatment have helped make cervical cancer relatively uncommon in the United States—about 10,000 women are diagnosed each year and 4,000 die—the vaccine would have a significant impact in poor countries, where cervical cancer is a leading cause of death among women. With little infrastructure for the preventative pap smears, few women have a chance to detect and treat pre-cancerous changes in their cervix. However, Merck is not marketing or lobbying their product in countries like Africa, where there is little capital to invest in such an expensive vaccine.

“In developing countries, we need to look to philanthropic organizations like the Bill Gates Foundation, because the pharmaceutical companies are not going to provide it for low cost any time soon. Vaccines are expensive to develop and the companies want to make good on their investment,” suggests Ms. Hanson.

In this country, the main benefit of the vaccine may be the long-term reduction in health care costs associated with screening, treatment, and follow-up for pre-cancerous cervical changes. Women who would benefit most from the vaccine are low-income and uninsured women. These women do not have access to regular pap smears, so they are at the highest risk of developing cervical cancer. HPV can lead to anal cancer in immunocompromised individuals, like those with HIV, so they are another high-risk group that would benefit from HPV vaccination. However, high-risk populations are nearly impossible to identify in adolescence, when the vaccination would be most beneficial.

This was a similar case with the Hepatitis B vaccine. When it was first introduced, it was recommended for high-risk groups. However, doctors had a hard time figuring out who the high risk groups were and it ended up being recommended for all children. This resulted in a serious decline in the number of new hepatitis B infections, from 260,000 in the 1980s to 60,000 in 2004, according to the CDC. Likewise, it may be hard to predict which women will not have access to pap smears, or will have a partner that passes HPV to them. Broad vaccination will likely prove to be the most successful approach. Unfortunately, Merck’s overzealous push for mandatory policies has left many people cynical and suspicious of the HPV vaccine, when we should be celebrating an advancement in preventive medicine. Not offering the vaccine to girls would ultimately be a failure on society’s part, but putting profits before lives was Merck’s.

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