Voting for cancer, against prevention


Yeah, it was a bit tacky of Merck to create a campaign to get government officials to require inoculations against human papilloma viruses that cause cancer — but, people!, we’re talking about preventing cancer here.

The Texas legislature voted for cancer, overturning Gov. Rick Perry’s ill-considered good idea to require vaccinations for school kids in Texas. In a state with top-notch anti-cancer research at M. D. Anderson Cancer Center in Houston and UT’s Southwest Medical Center in Dallas, it was an odd, odd thing to witness.

The debates are skewed by a general distrust and dislike of big pharmaceutical companies, and by the religious right’s view that it’s better that a young mother die of cancer than she should get even the faintest idea that might in only the most perverse mind promote pre-marital sex. Still, we shouldn’t fall victim to voodoo science claims against vaccines.

Are my views, tempered by years of work promoting public health and fighting disease, clear enough for you?

Owlhaven wins popularity contests among mothers who read blogs, and it often is tender and touching — hey, I read it from time to time. But recently Mary, Owlhaven’s author, fell victim to a propaganda campaign from Judicial Watch, a far-right-wing bunch that campaigns against the U.S. justice system and generally makes a conservative-gratuitous-poke-in-the-butt out of itself. Judicial Watch claims to have some secrets from having filed a Freedom of Information Act Request with FDA to get Merck’s reports to FDA of adverse events known about Gardasil, Merck’s proprietary anti-cancer vaccine.

I responded, of course — but my response didn’t show on Owlhaven’s comments. Blackballed? Spam filtered due to the number or length of links? I can’t tell. Mary said she emptied the spam filter without checking. So, I repost my response, below the fold, for your benefit.

Owlhaven’s entire post consisted of a link to the Judicial Watch press release, saying “you decide.” You should probably gander at the Judicial Watch rant before you read my rant.

I responded:

1. Judicial Watch is a conservative group that is skewed against public health measures. They’re not fond of clean water or clean air, either. They’re not known for advocacy for children. [Some hyperbole; not much.]

2. Judicial Watch, in its indictment of Gardasil’s safety, does not compare the safety of Gardasil with other vaccines, or lack of vaccines. Is three deaths high? It might be low. Judicial Watch doesn’t say — they are acting as alarmists.

3. Pharmaceutical manufacturers report all problems in people who got the vaccine during trials (yes, there are glitches; the point remains, Judicial Watch is using Merck’s data, voluntarily passed along; Judicial Watch adds unedified alarmism only). A blood clot within three hours of receiving a vaccine against a virus is highly unlikely to have been caused by the vaccine. As we learned with Bendectin — or should have learned — fetal abnormalities and other pregnancy reactions can be misleading. The vaccine (Gardasil) is not recommended for use on pregnant women — why didn’t these women disclose their pregnancies? The instructions to Gardasil say: “Anyone who is allergic to the ingredients of GARDASIL should not receive the vaccine. GARDASIL is not for women who are pregnant.” It would appear these women were sexually active; were they minors, active and withholding that information from their parents? The vaccine can’t be blamed for bad relations between parents and children.

Judicial Watch does not tell us what the results were from the placebo group. The FDA-approved information indicates there were a nearly equal number of adverse pregnancy reactions from the placebo group in research. That is, getting the vaccine is no more dangerous than not getting vaccine, to pregnancy (Here are the prescribing instructions:

http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf)

4. All vaccines carry warnings of all possible side effects. Since the swine flu issue (back in the Reagan Administration — care to count how many years?) vaccines regularly carry warnings of Guillan-Barre syndrome, though most have absolutely no indication of ever having caused the syndrome. It’s unfair, inaccurate, and alarmist for Judicial Watch to claim this as a particular problem for Gardasil — it’s a problem of life, and the dangers disclosed for the vaccine do not change the fact that you are about equally probable to get Guillan-Barre if you don’t get the vaccine. Causes of Guillan-Barre are quite mysterious.

5. Judicial Watch is very selective about their reports of death — not full disclosure. 17 deaths were reported in trials — 7 by auto accident (4 in the vaccinated group, 3 who got placebos — significant? “You decide.”)

Here is a more full report:

A total of 102 subjects out of 21,464 total subjects (9- to 26-year-old girls and women and 9- to 15-year-old boys) who received both GARDASIL and placebo reported a serious adverse experience on Day 1-15 following any vaccination visit during the clinical trials for GARDASIL. The most frequently reported serious adverse experiences for GARDASIL compared to placebo and regardless of causality were:

  • headache (0.03% GARDASIL vs. 0.02% Placebo),
  • gastroenteritis (0.03% GARDASIL vs. 0.01% Placebo),
  • appendicitis (0.02% GARDASIL vs. 0.01% Placebo),
  • pelvic inflammatory disease (0.02% GARDASIL vs. 0.01% Placebo).

One case of bronchospasm and 2 cases of asthma were reported as serious adverse experiences that occurred during Day 1-15 of any vaccination visit.
Deaths
Across the clinical studies, 17 deaths were reported in 21,464 male and female subjects. The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 placebo subjects), followed by overdose/suicide (1 subject who received GARDASIL and 2 subjects who received placebo), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 placebo subject). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, and 1 case of arrhythmia in the group that received GARDASIL, and 1 case of asphyxia in the placebo group.

What I posted is public record, in fact it’s available at the Gardasil site. It’s interesting that Judicial Watch filed a Freedom of Information Act (FOIA) request, since this information is generally public — but if one wishes to issue an alarmist press release, it does sound more dramatic if one claims one had to pry the information out of the government, so cloak-and-dagger-like.

Do you know any women who have had their cervix eaten away by cervical cancer? I know a few. Without a cervix, even if the women survive the cancer, pregnancy is generally close to impossible. It’s a devastating disease, killing way too many. Most women who get the cancer probably got the virus long before they thought they would. Cervical cancer kills young women as well as older women. Cervical cancer orphans young children.

Are you advocating cervical cancer? If we don’t present the case against cervical cancer, and the case in favor of the vaccine, we’re not working against the cancer at all. Did you weigh the dangers of cancer against the dangers of innoculation? Judicial Watch appears unconcerned about cervical cancer at all.

What about genital warts? The vaccine prevents 90% of genital warts – what do you think about them? Are warts better than the vaccine?

By the time they reach age 50, 4 out of every 5 women (that’s 80%) will have contracted HPV. HPV is a contact virus, so simply remaining chaste, or even celibate, may not protect against the viruses.

Take a look at the 1,637 reports of “adverse reactions” cited by Judicial Watch from Merck’s reports. They include minor swelling at the injection site, pre-existing viral and bacterial infections, and allergic reactions to pollen. Your kids will have those reactions without the vaccination, too – except for the minor swelling (which was reduced with an ice-pack).

If we’re going to put our daughters at risk of cervical cancer, we should check out the Centers for Disease Control (CDC) sites and get the real information before making the judgment. If your 25-year-old daughter dies of cervical cancer, leaving two pre-school kids without a mother, you may wish you had considered the full range of information.

According to the CDC:

The FDA has licensed the HPV vaccine as safe and effective. This vaccine has been tested in over 11,000 females (ages 9-26 years) around the world. These studies have shown no serious side effects. The most common side effect is soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use.

Update, May 2008: It’s been noted that the viruses cause oral cancers in men, too.  The vaccine is now recommended for boys as well as girls.  Some details, and a well-justified rant against “anti-vaxers,” at Pharyngula.

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14 Responses to Voting for cancer, against prevention

  1. [...] For example, from the numbers available when I wrote about this in May 2007: [...]

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  2. [...] favor of our children getting cancer”).  Dear Reader: Remember Heather Burcham, and remember the facts about HPV vaccines. Explore posts in the same categories: Texas history, Texas Lege, Public education, Public health, [...]

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  3. PalMD says:

    Most parents of children today do not remember the horrors of the pre-vaccine era. The strains of HPV covered by the vaccine are extremely prevalent, affecting millions of women yearly. HPV, in general affects a huge percentage of the population. Any decrease in incidence will have a large effect because of the huge prevalence of the disease. Probably, men will eventually be studied for the vaccine, but anal and penile cancer, both caused by the virus, are not as common as cervical cancer. I understand the mistrust of “Big Pharm” but, honestly, modern drugs and vaccines have done almost infinite more good than harm.

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  4. Pam says:

    For Alaska’s take on the vaccine, see Cancer vaccine now available – http://ykalaska.wordpress.com/2007/04/09/cancer-vaccine-now-available/

    Boys and men are carriers and also can get the disfiguring disease. There are references to the NHS Doctor’s take on the vaccine in Britain.

    But it is interesting that it took a commercial advertisement to bring the significance of the virus and its impact to the forefront. Pandemic flu and disaster preparedness is a far more imminent problem but too few medical and business people, far fewer local government and households are aware. See some of the entries at the new Pandemic Flu Leadership Blog http://blog.pandemicflu.gov/

    The posts are often stodgy, especially that by the Secretary of Health and HS and the design is difficult to read (not very accessible). The audience is limited.

    Basics of human biology and public health are one of those things that almost no one these days is taught even at the graduate level and yet everyone must have a basic understanding of. Looking out just for number one just doesn’t work; civics do/does.

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  5. Ed Darrell says:

    I’m no expert, though I did spend a lot of time in policy positions on health, earlier. I have cut my newspaper reading way back — I’m lucky to do more than one newspaper a day. I’m interested to hear anyone was surprised by the announcement of this vaccine. The development has been covered, albeit mostly in small articles, for years. The approval process was well promoted by Merck’s PR department, as well as with official announcements from FDA.

    And, as for HPV, that’s the scare virus that the “abstinence only” people have been using with your kids for years. HPV is a contact virus, and it’s often carried outside the zone protected by condoms, so the scare story is “condoms don’t protect against HPV.” Consequently, the development of the vaccine was thought, in the medical community, to be a benefit that everyone, including the abstinence only bunch, would hail. Opposition to the vaccine was a bit of a shocker — sorta like people saying they’d rather their kids have rickets than drink milk with vitamin D.

    But you all saw it coming out of left field, quickly, with no advance warning? Wow.

    What other news do we miss, that should be in front of us all the time? Interesting.

    Thanks for the comments. Much stuff to think about.

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  6. fireshadow48 says:

    I have learned something this day. I have learned (again) to be sure and read carefully, and I have learned that HPV can be passed through skin contact.

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  7. tanglethis says:

    There should be a “you” after the “but” and before the “might also want to check out the page.”

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  8. tanglethis says:

    Hi fireshadow, I think Ed has done a good job with the facts here, but might also want to check out the page where I’ve attempted to do the same in a different way. After all, I completely sympathize with the average citizen not having time to check into every medical release that hits the news–but since that doesn’t stop the average citizen from having opinions about it, I thought it’d help to round up info from a number of sources like the FDA and CDC and whatnot. It’s that HPV & Gardasil page linked above.

    I for one am not surprised that this vaccine seemed to come out of left field, without the lead-up hype you’d like. Before Gardasil was approved, hardly anyone knew anything about HPV, or cared. If there were life-saving news about an HIV vaccine, you’d better believe it’d be all over TV. But HPV, who’s heard of that? It’s not breaking news unless you can get the public’s hope or alarm worked up about it.

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  9. fireshadow48 says:

    I have gone back and read your article a little more carefully. I see you have answered some of my questions. Sorry, I jumped the gun on some of it.

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  10. fireshadow48 says:

    As far as side effects are concerned, I was speaking about pharmaceuticals in general. I admit I group vaccines in with all pharmaceuticals. My mistake. Thank you for clarifying this.

    I am not that educated in the medical field, which makes it all the more confusing for me. I am an average citizen, going about my daily life which does not include in depth reading on all subjects. I watch a little news, I read a little newspaper, but like most people, I have responsibilities. I must rely on the newspapers and the TV for most of my information. It would be a full time job just to keep up on all the news – medical being just one topic. So, I hear just enough to worry!

    I am glad there are those like you who specialize in this topic and are willing to educate those like me.

    What happened for me and others I have spoken with, was that this got sprung on us all of a sudden. I am not a conservative whacko, actually quite the opposite in many ways. But I do have a general mistrust. I think that if we had heard that the vaccine was on the way, and had time to think about it, we might have been ready for it. Perhaps this would have gotten more people on board with this. But to suddenly be told that our children would be required to take this new vaccine is alarming. It triggered the mistrust that I think runs through more people than just me. It felt like a rush job, and I mistrust a rush job.

    I would like to say for the record that I am glad the vaccine has been developed, and will be available.

    My reservations are about being forced. Is this virus contagious to the general population? Does it present a health risk to others if a young woman does not have the vaccine? Or does it present a risk only if she has sexual relations? I understand diseases like polio are a risk to the general population; that requiring vaccination protects the group. If the risk is limited to the individual, isn’t it a personal choice? Or will we be forced because “the authorities” know what is best for us?

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  11. Ed Darrell says:

    The long range effects of not taking the vaccine are cancers and warts. I suppose there could be effects from the vaccine, but it would be difficult for any long range effects to be more severe.

    I am unaware of any trend that suggests long-range, bad results from any vaccine. Polio, typhus, typhoid, measles, chicken pox, hepatitus B (another cancer causing virus preventer), mumps, whooping cough — none of them have long term bad effects. Flu vaccines? No long term bad effects.

    Where are you reading these effects? How could you read about them if they are not “announced” (especially since such effects are tracked by FDA)?

    Perry’s move was ill-considered, in my mind, solely because he didn’t get the conservative wackos on board first. The fight against the vaccine was more pique than substance, coupled with James Dobson’s bizarre favoring of any disease that might be sexually transmitted, as a punishment for sex.

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  12. fireshadow48 says:

    I certainly support prevention of cancer.

    However, I am leery of new pharmaceuticals. Are there long range studies? What are the side effects? No, I do not have children, but if I did, I would be alarmed at being forced to have my child vaccinated with something we were not completely informed about.

    I often read in newspapers and hear on TV about various medications having serious side effects. Usually these effects are not initially announced, but pop up over time. It makes it feel as if we, the general public, are the final test group. Sometimes, the side effects of a medication are far more serious than the original disease it was meant to cure. Sometimes it seems as if a person goes in for treatment of one problem, and soon develops a new problem for which another medication is given. Can you blame us for being leery?

    I agree that Perry’s move was ill considered, if indeed his intentions were good. How about an educational campaign first? And I mean real education; on the negative as well as the positive.

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  13. [...] Merck : Gardasil’s official site. Link to the Patient Product Information provided by Merck Centers for Disease Control and Prevention, HPV page. CDC’s fact sheet for men Food and Drug Administration: FDA Approves Gardasil National Cancer Institute: HPV Factsheet American Cancer Society: What Every Woman Should Know About HPV Judicial Watch on Adverse Side Effects Vaccine Adverse Effects Reporting System Ed Darrel’s response to Judicial Watch [...]

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  14. tanglethis says:

    Thank you for all of these links. I am about to compile a Gardasil infopage for my sexblog, http://www.sexcalumny.net, and though I intend to continue my own research, some of these pages will be very helpful.
    I might admit that I didn’t do any of this research before I jumped in and got vaccinated. I quizzed my doctor about it, perused the Merck website, and ultimately decided that I was I was most interested in preventing HPV–having it once was quite enough, and I don’t want to bank on being so lucky to avoid reproductive complications if it happens again. It’s not exactly preventable, this virus. Not without vaccination at least.

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