Judicial Watch tears into Gardasil...
...and a rogue epidemiologist tears right back.
You can read the World Net Daily Article here http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=58004
...and come back for my sass.
Judicial Watch, a conservative non-profit law firm, starts out with a scary citation: 8 women have died after being vaccinated with Gardasil, while another 1,824 cases of adverse reactions to the drug were reported. According to their statistics, there was a total of 3,461 of adverse events reported for Gardasil.
These numbers were taken from the Vaccine Adverse Events Reporting System (VAERS), the CDC-FDA registry for recording complaints about vaccines.
Some events are more adverse than other. Adverse events can include things like "pain at injection site." DUH! You just got a needle jabbed into your arm! Of course that's going to hurt! Some are truly legitimate, though. I'll concede fever is typical of all vaccines. Any time you ask your immune system to work a little harder (which is what all vaccines do), you do run a risk of having a fever. That's a common immune response. As for the other stuff, to get an adverse event listed on VAERS, all you have to do is say so. There is no attempt on the part of ANYBODY to try to determine any kind of actual correlation or CAUSALITY between the vaccine or its reported adverse events. Nobody will even verify your claim. VAERS is simply a repository for raw, unwashed data. it can be useful later when epidemiologists sift through the data. But as is, there a lot of chaff still stuck in that pile of wheat.
VAERS doesn't try to control biasing. People who report to VAERS often experience a phenomenon called recall bias. That means when a memorable event happens to people, people have an inclination to use it as a landmark and artificially connect that memory to other things. A common example I see here on Scarleteen is when girls try to associate widening of hips to initiation of sexual activity (i.e., I lost my virginity, and it's making my butt bigger). Well, that's a false correlation because sexual activity often starts during adolescence, a time when girls naturally grow bigger hips anyway; nonetheless, they mentally tie it to their first sexual encounter. Now apply this to the idea of recall bias to VAERS. If a person receives a vaccination -- especially one they are a little apprehensive about -- and they subsequently experience some symptom like a headache, they are prone to associate it with the vaccine, even though they may have had the headache for any other number of reasons. And like I said earlier, VAERS makes no attempt to verify, correlate or determine causality between the report and the vaccine.
"In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Tom Fitton, president of Judicial Watch. "These adverse reactions reports suggest the vaccine not only causes serious side effects, but might even be fatal."
Opponents like to argue that cervical cancer usually doesn't strike women until they're middle-aged, and therefore it is absurd to give the vaccine to young girls. However they fail to acknowledge that cervical cancer is a notoriously slow-developing, slow-growing cancer. Most people acquire HPV while they are still in their teens or early 20's. But the cancer itself usually doesn't become full-blown until the late 30's or 40's because the cervical cells can take years to mutate. Nonetheless, it's CANCER. It is dangerous. Treatment requires surgery, chemotherapy and radiation.
The most controversial point about Gardasil is it is a vaccine against a sexually-transmitted virus, and it is supposed to be given to children as young as 9-years-old. It is difficult to perceive children so young as being sexual, and this sets off a visceral reaction in a lot of people, especially parents of small children. But consider the vaccination schedule for Gardasil. It takes 6 months to complete the course of shots to acquire full immunity. Giving the shot well before a person is even contemplating sexual activity is important because of the nature of the decisions that go into becoming sexually active. When a person makes up his or her mind to have sex, it is a decision that usually goes into action within a short time frame, often on the fly. Judicial Watch (and like-minded people) want you to believe that a woman (who is a fully grown, heterosexual adult) will simply decide one day, "I think I'm going to start having sex. I should go get vaccinated with Gardasil." The problem is, once she gets into that mode, she will still need to wait 6 months to complete the vaccination course before she can confidently avoid HPV during her sexual encounters. In reality, who the hell waits that long after deciding they want to have sex??? You need to vaccinate the person before s/he gets to this point.
Another thing to consider is that plenty of adolescents are already engaging in activities that they may not know or consider to be sex, but still put them at risk of contracting HPV. Frottage (dry sex) is a real HPV risk because the direct skin friction can transmit the virus between two people. Again, you need to vaccinate the person before s/he gets to this point.
The last reason for vaccinating early is the most unpleasant to contemplate: RAPE. There are bad people in the world who want to harm others. Some of these people will commit acts of heinous sexual assault on young girls. Many of these poor victims, already traumatized by the indignity of the assault, will have to contend with HPV -- a potentially lethal sexually transmitted disease -- for the rest of their lives. As parents and as a society, we want to protect innocent children from harm. Protecting them from people who hurt them is one part. Protecting them from diseases (including diseases that could be a direct result of that harm) is another part.
Judicial Watch cited case reports of deaths following Gardasil vaccinations. here are a few choice examples:
"Information has been received … concerning a 12-year-old female with a history of aortic and mitral valve insufficiency … who on 01-MAR-2007 was vaccinated IM into the left arm with a first does of Gardasil … On 01-MAR-2007 the patient presented to the ED with ventricular tachycardia and died."
"Information has been received … concerning a 17-year-old female who in June 2007 … was vaccinated with a first dose of Gardasil … During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died."
"Initial and follow-up information has been received from a physician concerning an 'otherwise healthy' 13-year-old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced … paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered."
Another report stated that a woman was vaccinated and "died of a blood clot 8 hours after getting the Gardasil vaccine."
What Judicial Watch doesn't tell you is that many of the adverse event deaths included things like car accidents. The other thing they don't tell you is that these deaths were statistically insignificant compared to the un-vaccinated population. That means that between X number of vaccinated people and X number un-vaccinated people, the number of people reporting deaths or adverse events was approximately the SAME. No real difference between the two groups.
Let's also think of these numbers: According to the U.S. Cancer Statistics: 2003 Incidence and Mortality report, 11,820 women were diagnosed with cervical cancer in 2003, and 3,919 women died from the disease that same year.
Then Judicial Watch takes the "it was only tested for a short time" angle.
"Along with the potential of serious adverse effects is the question of efficacy. There is evidence that after approximately four years, the vaccine's potency significantly declines. The long-term value of the vaccine has yet to be determined; if it wears off within six years, will girls and women need to repeat the battery of injections they originally received?" the organization wondered.
This part is the most commonly minsunderstood thing about Gardasil. Most people don't know how a clinical trial is conducted, and I don't expect them to. I only know about it because I learned it in graduate school. Ideally, you try to follow clinical trial subjects for as long as possible. However there are certain conditions under which you are ethically permitted, if not REQUIRED to shorten the trial. The first condition is obvious: if serious harm that is directly attributable to your clinical trial hurts your test subjects, you halt the trial! The second condition is if at a certain check point in your trial you find that the treatment you are testing is equally as effective (or ineffective) as your placebo, then you halt the trial (this is why the HIV vaccine trials ended). Lastly applied to Gardasil. If your test drug (i.e. Gardasil) is vastly superiorly more effective than your placebo, then you stop the trial and give the treatment to everybody. In Gardasil's case, clinical trials showed it was 100% effective in preventing transmission of HPV 6, 8, 16 and 18 in the girls and women who received it. Let me repeat that number for you: 100%. That's stunning and pretty darn rare in the world of medicines. Very few things ever score that highly. And or the record, three-years with tens of thousands of test subjects is not a short time. That's a lot of person-years. And yes, observations are still ongoing, and people are still welcome to file a report to VAERS in the event they suspect something's wrong.
In conclusion, please bear in mind that the people who put out this report against Gardasil have their own bias and agenda. They generally oppose government mandates on things like vaccines. And they tend to be very socially conservative, including in matters pertaining to sexual morality.
I won't hide my own bias: I like preventing sickness. It's what I do. I have been vaccinated with Gardasil, and I didn't have any adverse events beyond, "Ow! You just stuck a needle in my bicep!"