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Friday, September 3, 2010

Strange Bedfellows: pro-sex activists, pharmaceutical companies, conservative christians and HPV (2007)

From Slingshot Issue 94

Slingshot collective, PiratePrentice, PB Floyd
The issue of the HPV vaccine is complex, there are different 'authorities' asserting different facts and people on both sides of the debate that we, as radicals, vehemently mistrust and disagree with. As a collective, we are deeply divided on this issue. Some of us come down on the side of doubting the merit and utility of the vaccine and discouraging its use, while others ultimately believe that the benefits of access to the vaccine outweigh the potential dangers of its use and our misgivings about Merck. Because of this we are running two articles on the issue. Conflict and differences of opinion can be difficult to work through, but its better than conforming to a party line. As always, If you take issue with anything we publish, let us know about it. Write: Slingshot Collective, 3124 Shattuck Ave. Berkeley, CA 94705.

Article #1:

By PiratePrentice

Sometimes, people can respond appropriately to situations for completely the wrong reasons. One of the largest pharmaceutical companies in the world is facing the loss of between $8 and 25 billion dollars in over 96,000 separate lawsuits. It is attempting to recover its losses by lobbying state governments for the mandatory vaccination of pre-pubescent girls with a new vaccine. By the company's own admission, this vaccine is only partially effective and the cancer it is designed to prevent is easily curable if detected early. It is obscenely expensive, has been inadequately tested, and numerous cases of severe side-effects have already been reported. This company is forced to abandon its lobbying efforts, not for any of the obvious reasons listed above, but in response to a formal coalition of the righteous Christian fanatics who believe it is against God's will to force children not to get cancer without their parents' approval as well as a loose association of individual Christian fanatics who believe that the vaccinations will cause young girls to have sex…

This scenario isn't imaginary. Merck Pharmaceutical (whose painkiller Vioxx was discovered to have caused heart attacks and strokes after long-term usage) recently was forced to abandon lobbying for the mandatory injection of their new HPV vaccine, Gardasil, for all 12 year old girls. Merck's mandatory vaccination scheme was opposed by numerous Christian conservative groups such as Focus on The Family and The Family Research Council because (according to the FRC's official website), "it would infringe upon parental rights to decide their own children's medical care, without sufficient public health justification… our opposition to mandatory vaccination is rooted in a concern about parents' rights, not about sexual behavior."

This is a direct contradiction of the views expressed earlier by the FRC and other Christian 'abstinence-only' sexual health groups when Gardasil was being tested/developed in 2005. Then Bridget Maher of the FRC stated that "giving the HPV vaccine to young women could be potentially harmful, because they may see it as a license to engage in premarital sex." (This opinion which is widely held among the 'abstinence-only' circles regarding everything from free condoms to needle distribution, is called 'disinhibition'.) But after over 100 lawmaker wrote letters to the Center for Disease Control (doubtlessly urged on by Merck lobbyists) requesting that the CDC avoid playing politics with scientific judgments, and assurances (+$$$?) by their local Merck representatives that "no evidence of sexual disinhibition had been found during trials of the vaccine", the FRC and other Conservative Christian groups reversed their position and decided that vaccinating pre-pubescent girls against HPV would not necessarily lead to rampant promiscuity. However, they were able to see far enough past the Merck hype (and $$$?) to realize the very direct dangers and doubtful benefits that the HPV vaccine offers. For this we all owe a very tiny debt of gratitude to all these conservative Christian groups despite their wacko beliefs. Because Merck's HPV vaccine Gardasil might turn out to be some truly evil shit and mandatory injections could result in a disaster.

Calling Gardasil a potential disaster is no exaggeration. This vaccine was rushed into the market by the Food and Drug Administration (FDA) using their 'fast track" process without adequate testing. For instance Merck has published clinical test results for only one other vaccine (hepatitis B) in combination with Gardasil. Many vaccines react adversely with each other and as you probably painfully recall from childhood visits to your doctor or public health nurse, multiple vaccinations are the rule and not the exception.

What's worse is that Gardasil may actually re-activate the latent HPV virus in patients already exposed to one of the HPV strains which the vaccine was designed to act against. Clinical trial results for Gardasil showed that , "…trial subjects who had already had exposure to the four strains showed higher rates of cervical neoplasia (abnormal cancer cell precursors), raising questions as to whether the vaccine impairs immune response under such circumstances, …".

The Center for Disease Control (CDC) has already reported over 540 complaints of adverse reactions from Gardasil. Between the introduction of Gardasil on June 8, 2006 and mid-February 2007 the National Vaccine Information Center (NVIC) reports that over 385 distinct case reports concerning the adverse effects of a Gardasil injection were reported to the federal Vaccine Adverse Event Reporting System (VAERS). Five of these VAERS incidents were described as life threatening and 6 as disabling. Two hundred ten (or 61%), had not yet fully recovered. Hospitalization was reported in 12 cases and two-thirds sought additional care in an emergency room or doctor's office. Adverse reactions included: pain of various types, fainting (55), dizziness (41), Partial loss of sensitivity to sensory stimuli (32), rash (33), itching (31), dilation of blood vessels(19), headache (19), and vomiting (16). There were also several reported cases of Guillain-Barre syndrome, a serious disorder in which the body's immune system attacks part of the peripheral nervous system, potentially resulting in temporary paralysis or even death.

Gardasil was designed to prevent HPV which causes many genital warts and can cause cervical cancer. HPV is the most common sexually transmitted infection (STD) with more than 50% of the sexually active population becoming infected sometime in their lives. There are over 100 strains of HPV with between 30 and 40 strains that are sexually transmitted and 15 associated with cervical cancer. Genital warts can be very painful, particularly in women, but most of the time the warts are benign, with any 'cure' being more painful than the disease. As noted in the previous sentence, 15 strains of HPV can lead to pre-invasive lesions, which can lead to cervical cancer. Fortunately, these pre-invasive lesions develop slowly, so virtually 100% of all cervical cancers can be prevented with regular Pap smear screening and prompt treatment. Virtually all of the recent cases of cervical cancer, reported in the U.S., have been among women who have not had regular pap-smears.

Gardasil can't even accomplish the task for which its manufacturers designed it. According to the Food and Drug Administration, Gardasil is effective against only 4 strains of HPV. Currently, these strains are responsible for 70% of the HPV infections which lead to cervical cancer and 90% of the infections which cause genital warts. 70% and 90% sound like pretty good numbers, but remember that over 100 strains of HPV exist and that any one of these relatively benign strains could rapidly evolve to replace one of its more harmful cousins.

Why was Merck pushing so hard to have a vaccine that is only partially effective and potentially dangerous mandated for young women in the United States? Well, Merck would have no legal liability for the vaccine's side effects if it were mandatory. Also, the cost of the vaccinations (it'll take three of them) is estimated to be $360 per patient. Multiply that by the number of girls entering middle-school each year and you'll have an answer to that question.

It is a shame that Merck was so greedy to get the fast buck (but expecting a large pharmaceutical company not to be greedy is like expecting to find fur on a fish). A safe, effective HPV vaccine would have eliminated the need for painful procedures to remove pre-cancerous and cancerous lesions in American and European women. More importantly, it is a vaccine that would have saved the lives of about 200,000 women per year in the developing world where women do not have access to regular cervical examinations and pap smears and cervical cancer remains their leading cause of death from cancer. Unfortunately, Gardasil is not that vaccine.


Article #2

By PB Floyd

The first time I became personally aware of HPV (human papilloma virus) was when I started dating Jenn and she told me she had been treated for it. She had caught it ten years before from a boyfriend and had to endure painful, embarrassing and invasive treatments. She hadn't had a re-occurrence since then, but the virus was likely present in her. Since condoms don't protect you from HPV (it is found in genital skin areas other than the penis and vagina that a condom doesn't cover) it meant that if I slept with her, I would be exposed, even though we were going to use condoms. At the time, in the heat of passion (don't these conversations always take place in such heat?) I didn't think clearly and I didn't have enough facts about what this meant. Over the next few months when I looked into the details, it started to hit me that now that I had been exposed, I would always have to tell any future partner about the risks if we shared a bed. It was really emotionally awful to come to grips with this -- I felt dirty and my future sex life felt ruined. Even though I never developed symptoms, I became extremely aware of HPV.

It was around that time that I learned that scientists were working on a vaccine that would prevent people from becoming infected with some strains of HPV. There are 100 kinds of HPV -- about 40 that are sexually transmitted. Some varieties can lead to cervical or rectal cancer. Other varieties only cause painful, embarrassing genital warts. About 5.5 million new genital HPV cases occur each year according to the American Social Health Association -- about 1/3 of all new STD infections. The personal trauma associated with each and every one of the these cases -- the doctor's visits, difficult talks with partners, feelings of loss and dirtiness, and physical pain associated with treatment -- is very considerable. If you're a guy, you don't get pap smears so you don't really know what you may have unless you see a wart, but you can infect your loved ones through your ignorance. Many varieties of HPV that cause problems for women have no symptoms whatsoever in men.

I felt excited at the possibility that the vaccine would soon be released. I knew I didn't have all 40 strains of HPV, so I figured if I got the vaccine, I might be protected against some strains I hadn't been exposed to. Also, I figured future partners who got the vaccine wouldn't be infected by me. Whew -- maybe my future sex life wasn't ruined . . .

The vaccine (Gardasil) released last year doesn't quite live up to my hopes and expectations, but it still offers some protection. According to tests with 11,000 women, it was virtually 100% effective in preventing infection by four of the 40 strains of HPV (types 6, 11, 16, and 18), including 2 strains that cause 70 percent of cervical cancers, and 2 strains that cause 90 percent of genital warts. The clinical trial found "no serious side effects" according to the Centers for Disease Control.

Controversy about the vaccine began almost immediately from Christian conservative groups. The vaccine will only work if you take it before you are infected with HPV and thus it is most effective when taken before a person is sexually active. Therefore, it is recommended that girls between 9 and 26 years old get the vaccine. Some fundamentalist Christians couldn't handle the idea of giving a vaccine to young girls designed to protect women from a sexually transmitted infection.

These Christians believe that the best way to prevent sexually transmitted infections is for people to remain virgins until they get married, marry a virgin, and then not have sex outside of marriage. Since the vaccine is only really necessary for people who violate those standards -- people with multiple, non-virgin partners -- the Christians apparently reasoned that a vaccine would "encourage" immoral behavior. This is the same type of reasoning some Christians use when they oppose sex education and access to birth control -- that "immoral" sexual behavior is a result of insufficiently harsh penalties for sex, like unwanted pregnancy and sexually transmitted infections. This kind of fundamentalist Christian thinking is, at its base, anti-sex. Fundamentalist Christians, not content to pursue their private, religious and moral beliefs themselves, seek to impose these beliefs on others. These Christians -- not all Christians, by the way -- are happy to put their version of morality ahead of women's health, and general human enjoyment of life and sex.

Perhaps because the federal government -- which approves drugs like Gardasil -- is under the sway of conservative Christians, the FDA put strange restrictions on the use of the vaccine. Most glaringly, the vaccine is approved for women, but not for men, even though both men and women get infected with HPV and can transmit it to others. My hopes of taking the vaccine myself were dashed! Another odd restriction is that the vaccine is only authorized for women 26 years old and younger -- even though many women older than 26 are sexually active and have not yet contracted all of the targeted strains of HPV.

Finally, because the drug was developed by the pharmaceutical industrial complex, the vaccine is extremely expensive: $360 for a course of three shots over six months.

Merck, the company that developed Gardasil, spent millions to promote the expensive vaccine by trying to get states to make vaccination mandatory for school age girls. There is no doubt that Merck's greed-based, heavy-handed manipulation of the public health process is deplorable. Merck's efforts caused a backlash from Christians and anti-vaccination activists such as the National Vaccine Information Center.

NVIC, a private advocacy group, has never met a vaccine they didn't dis-like. It is true, as they contend, that some people will have bad reactions to every vaccine. With Gardasil, the CDC has found primarily very minor, non-dangerous reactions such as "soreness at the injection site" and infrequently dizziness or nausea. There is no credible data showing worse side effects -- just fear, speculation, and hype. If there were worse side effects, they would have been identified during the clinical trial with 11,000 women, the results of which were carefully tracked and published for all to see. While Merck's marketing campaign was clumsy, there is no reason to think that the medical science behind Gardasil will cause a "public health disaster."

As with any medical procedure, the key in analyzing whether the vaccine does more harm than good is weighing the seriousness and frequency of negative reactions against the seriousness and frequency of the medical problem the vaccine is intended to address.

Each person has to make their own decision, but in my opinion, the minor negative reactions to Gardasil are totally outweighed by the protection the vaccine provides against HPV infection. In 2006, over 9,700 women were diagnosed with cervical cancer and about 3,700 died from it. Even according to the NVIC, no one has died from being inoculated with Gardasil. Many more women who never develop cancer have abnormal pap smear results after being infected with HPV and these abnormal results take a huge emotional and mental toll on the women who have to undergo treatment and further tests. (See Cara's article in Slingshot # 86.) Telling women that they should just be treated for cancer or HPV -- rather than avoid getting cancer or HPV in the first place -- is not justified given the minor and rare reactions associated with getting the vaccine.

I don't want the vaccine to be mandatory. To the contrary, I just want the vaccine to be made available, cheaply and widely, to everyone who can benefit from it -- men and women, young and older. People concerned with medical safety have to be careful not to play right into the hands of conservative Christians who are against treatments for sexually transmitted infections because consequences for "immoral" sex are "God's Will."

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