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.
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:
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.
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.
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.