The HPV Vaccine Issue
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I certainly think it’s a good idea for teen girls to get the HPV vaccine, but I don’t understand the logic behind it being mandated. The disease is not airborne or anything communicable like other diseases that kids get immunization for.
The religious right idea that it’s going to make teenagers want to have sex is just ludicrous, and symptomatic of the kind of people who’s never talked to a teenager (or been one). But mandated vaccination, especially with the close connection between Gov. Perry and Merck, just smells.
25 Responses to “The HPV Vaccine Issue”
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© 2000-2011 Oliver Willis
it’s not being mandated, it’s being recommended
http://www.governor.state.tx.us/divisions/press/exorders/rp65
WHEREAS, the Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention recommend the HPV vaccine for females who are nine years through 26 years of age;
NOW THEREFORE, I, RICK PERRY, Governor of Texas, by virtue of the power and authority vested in me by the Constitution and laws of the State of Texas as the Chief Executive Officer, do hereby order the following:
Vaccine. The Department of State Health Services shall make the HPV vaccine available through the Texas Vaccines for Children program for eligible young females up to age 18, and the Health and Human Services Commission shall make the vaccine available to Medicaid-eligible young females from age 19 to 21.
Rules. The Health and Human Services Executive Commissioner shall adopt rules that mandate [ed. see highlight below] the age appropriate vaccination of all female children for HPV prior to admission to the sixth grade.
Availability. The Department of State Health Services and the Health and Human Services Commission will move expeditiously to make the vaccine available as soon as possible.
Public Information. The Department of State Health Services will implement a public awareness campaign to educate the public of the importance of vaccination, the availability of the vaccine, and the subsequent requirements under the rules that will be adopted.
Parents’ Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children’s health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.
The reason for mandatory vaccination is that the vaccine is really only effective if given to girls before a certain age. If the decision is left to their parents many girls simply won’t get vaccinated. When they turn 18 and can make their own decision, it’s too late.
That’s their parent’s fault and business, isn’t it? The government can’t parent every kid.
Why should parents have to opt-out of this process? Do you approve of opt-out to get out of spam lists? Opt-out to get out of telemarketers?
If you read the drug trial information, the drug was never proven effective for girls in the age range they want to give it to. The drugs efficacy was “inferred” from other evidence. The drug is only supposed to be effective for 5 years, and most women that get this disease will not get it until their 20s to 40s. The control injection was contaminated, and there was no long term follow up for side effects, but even in the short term, some number of women 16-25 got arthritis.
Why the rush to give this vaccine now over parents objections? What will medical science discover in the 10 to 30 years these girls have?
Parents should have to opt out of this process for the same reason they have to opt out of the polio vaccine. The transmission method is irrelevant. HPV is an extremely prevalent virus: “According to a 1997 American Journal of Medicine article, nearly three in four Americans between the ages of 15 and 49 have been infected with genital HPV at some point in their life.” Wishing it not to be so doesn’t make it not so.
The other reason to make it mandatory is that otherwise, lower income people won’t receive free vaccine, a huge percentage of the population won’t be vaccinated, and the chance to eliminate HPV from the population will be lost.
Additional details. In the diary someone states that it can be passed through hand contact, although I suspect the conditions for that are unusual.
http://www.dailykos.com/story/2007/2/3/92516/02900
I am rather amazed that none of the reporting of this issue quite understands the real point of the immunization. The female’s first sexual contact may well be with her husband, but WHAT ABOUT HIM? If he has already picked up HPV and transmits it to her, should she pay with HER life for his prior activities?
The immunization has to be given when she is young for it to be effective. The misnamed “pro-lifers” are being utterly disingenuous when they say it is a license for females to have sex. NO! It will merely protect them from death that could result from their sexual contact with even a single man, their husband, if he has already contracted it!
They’re not “pro-life” – they’re anti-sex, and apparently even anti-sex within the marital relationship, if they want the woman to pay with her life for having sex with her husband.
Has everyone forgotten the principle that when you have sex with someone, you’re really having sex with everyone they’ve ever had sex with? Think!
The Guttmacher Institute has a good summary of the issues surrounding universal HPV vaccination here.
The “it’s not airborne” issue is addressed:
“[...]For example, states routinely require school-age children to be vaccinated against rubella (commonly known as German measles), a typically mild illness in children, to protect pregnant women in the community from the devastating effects the disease can have on a developing fetus. Similarly, states currently require vaccination against certain diseases, such as tetanus, that are not “contagious” at all, but have very serious consequences for those affected. And almost all states require vaccination against Hepatitis B, a blood born disease which can be sexually transmitted.”
I’m just wondering for those complaining about the “big brother” concept, etc., against the HPV vaccine – how many of you 1. have HPV and 2. have a daughter?
Lucky me I have both, as do several other women I know. I contracted HPV from my husband.
Unlike my husband however, whose biggest problem is the remote chance that he may have an outbreak of genital warts someday and have to get them burned off/frozen off (not because they are a danger to him, mind you, but because they’re just ugly/nasty/take your pick of negative adjectives and insert here), I have an expotentially increased risk of cervical cancer in addition to the joy of the burning/freezing. Try having acid placed on any part of your genitalia sometime before you knock the vaccine, and consider the idea that your future wife could contract this from you and end up having to have her cervix removed or in the worst case end up dead. My doctor actually commended me for not crying when I had to have this done. Unpleasant is an understatement. Even more dangerous are women who get the disease without even knowing it (because certain strains do not cause outbreaks even in women), who will only find out when and if they get their papsmears done and they come out irregularly, which just happened to a dear friend of mine last month who also contracted it from her husband.
Unlike you guys Oliver, we women are in serious danger here.
Having a little girl, I was absolutely thrilled when they came out with the news on this vaccine and you bet that she’ll be getting that shot.
I think the issue, Oliver, as pointed out above, is that insurers and Medicaid will only pay for the vaccine if it is mandated. Many women won’t get the vaccine simply because they can’t afford it if it isn’t paid by their insurance. It also becomes part of routine childhood vaccinations, causing fewer people to miss it.
Nothing here from Pedro? Where does our resident Good doctor weigh in on this?
HPV is utterly communicable. There’s every reason to mandate the vaccine.
Sorry Oliver you missed the boat here. The idea from a public health perspective is to create a herd immunity to the disease. That is why it needs to be mandatory, just like any other vaccine. In fact, I would like to see my teenage son get it as well, but right now they are reserving it for girls.
This is a public health issue that is being distorted by anti-sex nutjobs. We do not allow parents to opt out of the battery of vaccinations required to attend school. Why should this be any different?
Since I almost never read right wing site, I have only seen this discussed on left wing sites including C&L, TBogg, Pandagon, and here.
At all those sites, a significant number of people are alarmed about the mandatory nature of this vaccine due to its unproven nature and the lack of long term studies.
It is a red herring to claim that this is being distorted by anti-sex nutjobs.
Jerry,
No, the red herring is the attempt to claim that the vaccine is unproven. It has gone through a rigorous process of being approved after producing remarkable results. Do you view other FDA aproved drugs as unproven?
The limited reaction against the vaccine has originated almost exclusively with the “abstinence only, keep our girls ignorant, it’s better for them to die than do the nasty” crowd. These are the same people who don’t want kids to have access to birth control, don’t want them taught comprehensive sex education and want abortion criminalized to punish people for having sex of which they do not approve.
“Do you view other FDA aproved drugs as unproven?”
Huh? Yeah! Vioxx, DES, Thalidomide, Depo Provera, Premara, Baycol, … All approved FDA Drugs! Woohoo!
You have absolutely no evidence that the reaction is “limited”, and no evidence that the limited reaction is due in any significant amount to abstinence only people.
Further, you clearly have no idea how this drug was tested. It was a) FASTTRACKED, and b) efficacy in the target age of girls WAS NEVER PROVEN, BUT ONLY INFERRED from other reactions they saw.
So yeah, the drug is unproven and you have no idea what you are talking about.
Jerry,
I am married to someone who works exclusively in the area of women’s health, reproductive rights, and related issues. She has a masters degree in public health from one of the top universities in the country and has over a decade of experience on these issues. It doesn’t make me an expert, but she has been involved with this thing from the ground floor and I have been aware of its development for quite some time.
Do you have kids Jerry? Did you get them vaccinated and immunized from polio, diptheria, tetanus, etc?
Again, limited and marginal would be an accurate description of the opposition I have seen toward the vaccine, driven almost exclusively by the abstinence only crowd. I have yet to see anyone who is respected in the field of public health speak against it. I challenge you to name one expert in the area who has expressed disapproval of the vaccine. Almost all of the opposition appears tied to the idea of this being a vaccine for a sexually transmitted disease and that this is somehow different than mumps or TB.
If a similar vaccine were avaiable for HIV, would you want your children to have it? Again, as the father of a teenage, I can say unequivocally that I would.
Yes I have kids. Yes I had them immunized for most but not all illnesses depending on conversations we had with their doctors concerning the illness and the vaccine.
Everyone thinks it is great their is a vaccine. Many people think it is bad that it is mandatory. Many people are aware that the FDA processes are flawed, especially the past six years.
You want to ignore the FDA’s abysmal track record.
And then when faced with significant opposition, you want to marginalize that opposition by claiming they are all religious and/or sexually repressed nutjobs.
That’s your problem, not mine.
Lots of m.ds, doctors have come out against it, not because the vaccine itself is a bad idea, but because this one in particular was poorly tested, and there is no epidemiology to make it mandatory at this point in time.
You are the individual with your head in the sand, and I will prove that in just a moment.
But the facts are, this vaccine is poorly tested, and the disease while bad afflicts mainly women that don’t have regular pap smears. An alternative is to improve women’s health care overall. As one doctor said in a letter to the editor, there is no pap smear lobby but there is a vaccine lobby. Why not make sure pap smears are cheap and easy to get. Why not put mobile pap smear or women’s health clinics and send them around.
Now, the proof your head is in the sand?
Ketek. In upcoming days there are going to be hearings to determine how Ketek was approved and whether its approval was fraudulent. And how Ketek is used and whether it was improperly tested on children in the US and in foreign countries.
But no, klein, you are going to lecture me about my being a sexually repressed religious wingnut and tell me that my and lots of other parents’ concerns about injecting our kids is wrong.
But Ketek is today, Mr. Head In the Sand.
http://www.scoop.co.nz/stories/HL0606/S00220.htm
Congressmen On War Path Over FDA Approval Of Ketek
By Evelyn Pringle
French drug giant Sanofi-Aventis has stopped enrolling pediatric patients in clinical trials for Ketek. On June 9, 2006, the drug maker said it halted tests on its own to ensure that trials of the drug complied with FDA requirements.
The company denied that the studies were suspended because of safety concerns. However, the move jives with the recently initiated investigations into the FDA’s collusion with Aventis in the approval of Ketek by two powerful Congressional Committees.
The FDA’s conduct regarding Ketek is under investigation by House Representatives Edward Markey (D-MA), and Henry Waxman (D-CA), senior Democrats on the House Energy and Commerce Committee. On May 1, 2006 the lawmakers sent a letter to the FDA questioning its actions surrounding the approval of Ketek.
In a press release announcing the investigation, the lawmakers said, “though the FDA has consistently assured the public of Ketek’s safety and efficacy, public documents obtained and examined by Reps. Markey and Waxman’s staff indicate that the approval process for this drug was seriously flawed.”
Most recently, on June 8, 2006, the Senate Finance Committee sent a letter to the FDA asking: “Is the FDA considering temporary suspension of these trials until the serious concerns and issues related to Ketek are resolved?”
The company had been testing Ketek for treatment of ear infections and tonsillitis in nearly 4,000 children in the US and a dozen or so other countries. A search of the Clinical Trials.gov web site shows three ongoing trials in the US of children ages 6 months to 13 years, including:
…
Among the most serious allegations about Ketek is that the FDA approved the drug despite unresolved questions about the drug’s safety and efficacy, with full knowledge that some of the clinical data submitted to support the drug’s approval was tainted by integrity problems. Documents provided to the Senate Committee show that at least one of the clinical trials, Study 3014, was fraudulent.
In April 2001, Ketek’s initial approval came before the Anti-Effective Drugs Advisory Committee to consider whether its efficacy in treating respiratory infections supported its use given the risks of cardiac and hepatic toxicity and vision problems associated with Ketek.
Based on these concerns, the AIDAC recommended that Ketek not be approved and said Aventis should conduct a large clinical study. A letter to Aventis dated June 1, 2001, said in part: “This study should include the monitoring and analysis of all adverse events, with particular attention to hepatic, visual, cardiovascular, and vasculitic adverse events.”
Aventis subsequently hired Pharmaceutical Product Development (PPD) to conduct a study designed to enroll patients with respiratory infections in the offices of more than 1800 primary care physicians all across the country. Subjects were randomized for treatment with Ketek or Augmentin, another antibiotic.
In October 2001, doctors began enrolling subjects and were paid $100 for each patient they signed up, and another $150 when they submitted study results, as well as a final $150 after all questions were resolved, according to the May 1, 2006 WSJ.
The potential for money-making by doctors enlisted for this study was enormous. A fact that obviously did not go unnoticed by certain physicians who signed on to the study.
On July 24, 2002, Aventis submitted the results of Study 3014 to the FDA, but without fully disclosing the study’s integrity problems.
When the AIDAC reconvened to consider the study, the FDA presented it to the panel without disclosing that the agency’s Division of Scientific Investigation and Office of Criminal Investigation were investigating both the conduct and integrity of the study. Without the benefit of this information, the AIDAC voted to recommend the approval of Ketek.
In the end, a March 25, 2004 memorandum, prepared by the Division of Scientific Investigations titled, “DSI Recommendations on Data Integrity,” states that Study 3014 involved “multiple instances of fraud” and that “the integrity of data from all sites involved in [the] study … cannot be assured with any degree of confidence.”
In a press release on May 1, 2006, Senator Grassley said he was concerned about the FDA’s complicity with the drug maker and subsequent failure to ensure the integrity of a pivotal study about the benefits and risks of Ketek. Specific allegations under investigation by the Senate Committee include that FDA management:
(1) accepted the resubmission of a new drug application for Ketek, which included fraudulent data in support of approval;
(2) presented fraudulent study data to an advisory committee tasked with recommending Ketek’s approval or disapproval;
(3) instructed FDA scientists appearing before an advisory committee that they should present fraudulent data because discussing issues regarding data integrity and the conduct of the safety study would not be “productive;”
(4) approved a pediatric clinical trial, involving infants as young as six-months old, despite concerns related to known toxicities, including hepatic, visual, cardiovascular, and vasculitic adverse events; and
(5) continued to knowingly cite the fraudulent study in publicly released safety information on Ketek.
Given that the advisory committee had recommended conducting Study 3014 in the first place, theses allegations are “all the more outrageous,” according to Senator Grassley.
The AIDAC members certainly would have been interested to know that the highest enrolling doctors were being investigated and that there appeared to be significant under reporting of adverse events.
For example, the investigator at the highest enrolling site, Dr Ann Campbell, was found to be enrolling patients when the clinic was closed, and patient consent forms had date modifications and signature inconsistencies.
Dr Campbell had a practice in Alabama, that attracted patients by advertising weight-control treatments. “By the middle of January 2002,” according to the May 1, 2006 Wall Street Journal, “she had signed up 287 patients and was receiving enough of the drugs to enroll 30 new people a day, according to emails sent by a PPD employee on Jan. 15 and 17.”
On February 27, 2002, Nadine Grethe, an Aventis manager overseeing the study, got an email from PPD warning that there were possible problems with Campbell including the lack of “proper diagnosis of an appropriate medical condition,” medical charts described as “very limited,” and lab test results that were “suspiciously similar” for multiple patients. PPD also found that many patients signed up during a lunch break when the office was supposed to be closed.
The suspicions were validated on August 29, 2003, in the case of Maria “Anne” Kirkman, MD, aka Maria “Anne” Kirkman-Campbell, DOH Case No 2004-20974, when Campbell was charged in a 21 count indictment in the US District Court for the Northern District of Alabama with 10 counts of using a scheme or fraud to obtain money and property by means of false pretenses and documentation, and 11 counts of knowingly and willingly making and using, and causing to be made and used false writing and document knowing it to contain a materially false, fictitious and fraudulent statement and entry.
The information alleged that Campbell falsified documentation released to a study to establish the safety and effectiveness of Ketek before it could be a approved by the FDA.
Despite all this, when Aventis submitted the results of Study 3014 to the FDA, they included 407 of Campbell’s patients, and “did not alert the Agency to any problems” with Campbell, according to a review of Ketek’s history, safety and efficacy by FDA official, Dr David Ross, on the FDA web site.
Campbell was eventually sentenced to 57 months in prison and was given an additional 3 years of supervised release after the prison term is completed. She was also fined $557,251 and ordered to make restitution to Aventis to the tune of $925,774.
…
It goes on and on.
If an HIV vaccine comes out and it looks like it was tested and approved improperly, I will recommend my kids do not take it.
And you would be an idiot to do otherwise. Amazing to think you work for a PI lawyer.
Gov. Rick Perry’s chief of staff met with key aides about a new vaccine to prevent cervical cancer on the same day its manufacturer donated money to his campaign, documents obtained by The Associated Press show.
WE MUST VACCINATE! WON’T SOMEONE THINK OF THE CHILDREN!?
I’ve just been letting everything pass me by lately. I haven’t gotten anything done today. Pfft.
I’ve just been letting everything wash over me recently. So it goes. What can I say?
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