February 23, 2007 9:43 AM
Gardasil: HPV vaccine and parental rights
Moms - I know we're busy, but part of our job as The Hand that Rocks the Cradle (I've run this poem before and will run it this morning too) is to keep an eye on our kids' future.
There is an ongoing struggle in this country between parents and the government for control of our children's lives. If your children are very young, you may not have experienced it so much, because a lot of the control issues go on in public school.
But there are larger issues that unless you have the time to keep up with the news, you might not know about. Or if you hear the mainstream media spin you might not understand the significance of in terms of the ongoing encroachment on parents' rights.
Eighteen states are now considering making HPV vaccinations mandatory for school enrollment for pre-teen girls. It certainly does sound good, doesn't it - the first vaccine against cancer? But look who's pushing it: Merck - a mega-drug company who stands to make millions. And since the cancer in question is caused by sexually-transmitted disease, many parents hopeful of raising children not at risk for STDs would understandably not want yet another vaccine pumped into their bodies. Did you know that many parents of children with autism think it is linked to vaccinations?
Whether or not we individually feel called to take a stand on such issues, we need to understand. We need to protect our parental rights and exercise them intelligently. My kids are in public school, but I opt them out of sex ed because I believe it's my responsibility as a parent to teach my kids about this in the proper context. I'm completely amazed - living in the supposedly Christian community I live in - that very, very few parents opt their kids out of sex ed. The herd mentality is just so strong - so easy to just go with the flow, so hard to go against it.
Two items for your attention - a letter from a reader and an up-to-the-minute report from ABC News:
Barbara:I know that you are very busy, but I thought I would ask for your advice/opinion on a situation that I find very disturbing. I'm writing because I look to you as someone who has firmly rooted morals, and strong beliefs about the importance of family and parental authority.
Like most people, I was aware of Merck's new drug for some strains of HPV, Gardasil, through their ad campaign and the news of Texas Governor Perry's Executive Order that all girls entering sixth-grade (starting in 2008) receive this vaccine.
In doing more research, I was very upset to find that both the New Jersey State Assembly and Senate have bills before them requiring the HPV vaccine for girls in grades 7-12 for school admission, beginning in the 2007-8 school year.
This issue is very close to home as I have two daughters, ages two and eleven. My eleven year-old will enter 7th grade in the fall of 2008.
Until now, I had naively assumed that I could 'opt out' via a religious objection. New Jersey law allows for medical and religious objections, but the religious objection states that parents must demonstrate how "the administration of the vaccine conflicts with the bona fide religious tenets or practices of the parent or guardian, or student, as appropriate; except that a general philosophical or moral objection to the vaccination shall not be sufficient for an exemption on religious grounds." (I do feel that this vaccine conflicts with my religious tenets as HPV is only sexually transmitted and the Catholic church teaches that sexual activity outside of marriage is immoral; however, I don't know how that would translate into my daughters actually being exempted from the vaccine).
Personally, I have many concerns regarding this vaccine--lack of long-term studies (neurological, autoimmune, reproductive concerns), questions about the length of protection and need for boosters, the assumption that my daughters need to be "caught" before they have even entered puberty under the assumption that they will engage in sexual behaviors at a young age, as well as the connections between Merck and legislation being introduced around the country (and the huge profits they stand to make if such laws pass).
However, my main objection to mandating this vaccine is that the state is overriding the rights of parents to decide what is in the best interest of their children. Human papillomavirus is *solely sexually transmitted. This is not a public health threat along the lines of diptheria, pertussis, and other communicable diseases contracted through casual contact. I am outraged that the government would mandate something that should be up to the individual discretion of families and their health care providers.
I intend to fight this legislation. I am drafting an email to send to friends with school-age children as everyone I have spoken to is totally unaware that such legislation is being considered, and plan to write my legislators (ironically enough, *my state senator is a primary sponsor of this bill). I also plan to write letters to church leaders, newspapers, radio and television. Do you have any other suggestions as how to effectively block this legislation?
Thank you.
Sincerely,
Katie H
Katie wrote me 2/14. Since then the story's been developing. Here's the latest from Texas - where it's been revealed that on the same day Governor Perry decided every preteen girl in Texas should be required to receive the Merck vaccine, Merck contributed to the Governor's campaign:
Merck's Push for HPV Vaccine Caught Up in Political Intrigue Drugmaker Backs Off Vaccination Campaign; New Report Reveals Contributions to Texas GovernorDrug giant Merck & Co. announced Tuesday that it would suspend the mandatory vaccination campaign for its HPV vaccine Gardasil.
By DAN CHILDS, ABC News Medical UnitFeb. 22, 2007â The manufacturer of Gardasil, the first-ever vaccine shown to prevent cervical cancer, is facing growing opposition to the product's widespread use among pre-teen girls.
But many of the problems are political, not medical. According to documents obtained by The Associated Press, Texas Gov. Rick Perry's chief of staff met with key aides about the human papillomavirus vaccine the same day drug giant Merck & Co, the manufacturer of the vaccine, donated several thousand dollars to his campaign.
Chief of staff Deirdre Delisi's calendar shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16, according to The AP report. That same day, the documents show, Merck's political action committee donated $5,000 to Perry and $5,000 total to eight state lawmakers.
The revelation may provide ammunition to those in many states who oppose mandatory vaccination campaigns for pre-teen girls. On Wednesday, a House committee voted to rescind Perry's executive order requiring vaccination for girls in Texas.
Meanwhile, conservative family groups in Minnesota have criticized similar proposed requirements there, maintaining that such a plan would encourage promiscuity.
And in Connecticut, state health officials say they are concerned similar proposed legislation would be premature, citing a lack of available safety data.
The developments have added a new round of political heat that Merck had sought to avoid. Merck announced Feb. 20 that it would suspend its own campaign urging states to implement mandatory vaccination programs for pre-teen girls with its human papillomavirus vaccine.
Read rest of story here.
Moral to parents: Bringing up kids today is about a lot more than birthday parties, soccer games and college funds.
Stay informed!!
Posted in Current Affairs | Permalink
Comments
I have an idea I'd like to put forth for all of you to consider.
Some statistics I have seen suggest that up to 1 in 4 children will be sexually molested in some way. This really hits home for me because growing up, one of my siblings was sexually molested by a neighbor.
The reason that my son, who is at low-risk for hepatitis b, was vaccinated is because I don't know he'll always be low risk. And while I can teach him proper principles, I cannot guarantee he will not be sexually active before marriage and monogamous after.
I'm by no means suggesting that a vaccine that has yet to be proven safe should be promoted as viciously as it is being, but I simply wanted to give you a little more food for thought in this matter.
Posted by: Emily | February 23, 2007 11:08 AM
Every time I read or hear about this, my blood boils. I have a two year old daughter and so it hardly affects me at the moment, but this effort (and so many others) to take away parental rights to make choices in regard to their medical care strikes a bad nerve.
I hate the deceiving way they are campaigning this across pediatrician office doors as "saving my daughter from cervical cancer" and the sticky sweet or female-power-driven commercials that encourage me to make my daughter be "one less".
I will teach my daughter about choices and consequences. I can protect her from cervical cancer that is brought on by HPV by teaching her about the way that God views her and being sure I protect her sense of self-worth and confidence; by teaching her about the way and reasons God planned for intimacy between a married man and woman and fostering and protecting her relationship with her dad until she's married.
Posted by: Laura | February 23, 2007 11:11 AM
Barbara, I enrolled in college this semester, and, before being accepted, I had to get a MMR shot that I didn't get as a child. When I went to our family doctor to get it, the nurse told me the doctor said I also needed to get two other vaccines, one of which was Gardasil. I asked the nurse, "Isn't that the one for HPV." She confirmed it was, and I asked, "So why does he think I need it." She told me because of my age (I am 23). I looked her dead in the eye, and said, "I'm married." Being a lady in her fifties, she just kind of nodded and shrugged, and said she was just passing along what the doctor said. I assured her that I was not at risk for HPV or any other STD, and declined the vaccination.
The interesting thing that she told me, though, was that the vaccination cost about $500 and insurance would not pay for it. So, I'm wondering, is the government going to pay for these mandatory vaccinations, or are these parents expected to just come up with $500 per daughter.
I think the whole thing is ridiculous. Am I the only one that thinks that getting an STD is a logical consequence of sleeping around? I don't think we should be giving kids a free pass to do so.
Posted by: Rachel | February 23, 2007 11:56 AM
Hi Barbara,
I have lots to say about this vaccine, but I'll try to keep it short here! (I'll probably fail though! Your posts always seem to inspire a novel from me!)
First, the HPV vaccine does not protect the general population from infection, as HPV is not easily transmissible (as opposed to, say, measles. You can get measles if someone breathes on you, thus it is a concern for a public classroom. Since girls are not having sex in a public classroom with all of the other students, it does not protect the public health in the same way.)
Second, I have not seen or heard of a single study proving the long term safety of this vaccine for prepubescent girls (they are advocating giving it to children age 9-13). Adults were followed for 14 days for adverse reactions. According the Merck website, only the effectiveness of the vaccine (whether subjects became immune) was tested on 1471 girls age 9-17; there is not a breakup of pre- and post- menarch girls. If you happen across one, let me know! In fact, the official prescribing info on the Merck website states that Gardasil HAS NOT been tested for carcinogenicity or genotoxicity! (cancer causing or DNA mutation causing) Also, again Merck's own information indicates it may cause or bring out arthritis - 5 cases in Gardisil patients vs. 2 cases placebo; 1 case of juvenile arthritis vs. 0 placebo. Also the methodology of the placebo has been questioned (it contained aluminum, just like the vaccine)
Third, I do know that I personally have been harmed by vaccines - while at the Dr's office and watched him deny it while I was standing in front of him having a reaction! Many, many people suspect they have been harmed by vaccines; one should carefully weight the benefits vs. risks before taking any medication or shots.
Fourth, Merck is pushing HARD for this to be mandatory and the states are jumping on the bandwagon awfully fast! In the past, some vaccines have been shown to have unintended side effects, such as fatal twisting of the intestines. The vaccine was only invented a little while ago and now suddenly there are all of these laws, pushed through in haste. I really think we need to step back. There's a big difference between making a new medication/therapy/vaccine available and requiring it by law!
Fifth, THREE injections, over a 6 month period, are required. This could be an untenable burden on families without health insurance or in families where it is difficult for a parent to take time off of work. Yes, I know there is FMLA - and I also know first hand how that works for low level employee or small business!
Finally, I am Catholic. I also have a burden for proving religious exemption (in my state, I had to take a class and get a notarized document for my children, even the one not school aged, to be exempt. Apparently, in South Carolina, you are not allowed to exist if you have not been vaccinated). There is a church document called "Familiaris Consortio", by Pope John Paul II in 1981. It is an official document of the church (full text from Vatican website here.) It states that the right and duty of parents to direct their children's education cannot be entirely delegated or usurped by others.
Canon Law 1136 states that "Parents have the ...primary right to ensure their children's physical, social, cultural, moral and religious upbringing".
These are what I cite when a bureaucrat tries to tell me Catholics don't object to vaccines. The point being, Church Law specifically relegates those decisions to PARENTS and specifically states that they can't be usurped by the state. So, Catholics believe it is the parents decision - that's our "religious belief".
Usually, if you start bringing out page after page of papal documents, the bureaucrat will just stamp you through and not even look at it. In America, as well, you don't have to be part of a big, mainstream denomination to be exempted - it is YOUR personally held religious beliefs.
Here's another link to a Vatican document prepared specifically for parents wanting to opt out of vaccines created using aborted fetal cell lines:
http://www.immunize.org/concerns/vaticandocument.htm
It came out before Gardasil, so that is not addressed. I couldn't find out if Gardisil was created using human cell lines, but I'm working on it.
Every one of us makes a difference if we stand up and oppose this. Even if it seems like we're the only ones!
Posted by: Milehimama | February 23, 2007 11:58 AM
yet another case of "big brother" telling us what we should and shouldn't do.
As someone who had stage 4 precancerous (dysplasia) caused by, yes, HPV, I would have welcomed the vaccine in my younger, more immoral days. But I resent the fact that a state will tell me that my child can not attend middle/high school if she doesn't take this vaccine. I will teach my daughter right from wrong. My mom didn't teach me; I learned the hard way through many long hard years. But I will teach my daughter abstinence. That is the only SURE way to prevent any STD. And if the public schools tell us she can't attend, I will find a way to send her to private school. And what of the boys? They aren't required an additional vaccine...why not force them to take salt peter (which, of course, is a myth) in order to prevent their sexual urges, which would then take the onus off the girls.
It is up to US...the parents, to make these decisions. I decided to immunize my daughter, knowing that she would be sent to public school. Had I chosen not to, I would have had to decide about homeschooling...but it is MY choice, not the government's right.
Posted by: linda | February 23, 2007 12:25 PM
I think the ad campaign for this is incredibly deceptive, too. It is absolutely NOT a "cancer vaccine". It is a vaccine that is supposed to guard against *some* strains of HPV, which is always transmitted sexually.
I wonder how long it will take, and how many girls will suffer side effects (there have been some already) before the FDA rethinks approval or states rethink mandating it?
Posted by: Margaret | February 23, 2007 1:39 PM
Let me first say that totally agree with what you are saying here. I totally agree that this vaccine is rediculous!
The thing that we tend to forget is that NO vaccine is MANDITORY. No one can make you put something into your body that you don't want to. Now they can make it really hard on you ifyou don't and make your life difficult but they can't make you get a vaccine.
Posted by: Amie | February 23, 2007 3:06 PM
I remember when doing research that someone said something about vaccines violating God's law because of something with blood. So I did a search and came up with an a plethora of Bible verses. Three good pages were:
http://www.geocities.com/titus2birthing/VacExempt.html
http://www.vaclib.org/basic/religion-arizona.htm
http://www.vaclib.org/news/religion.htm
I did a google search for vaccination blood bible and found lots of verses.
Posted by: Paula | February 23, 2007 4:49 PM
Okay, a couple points really quickly -- HPV is caused by a number of viruses/factors, and Gardasil contains 4 viruses which will protect against 70% of cervical cancer. That means that 30% of people with the vaccine will still get cervical cancer, should they come across the "other" viruses that cause it.
Also, PAP tests are extremely useful and an early diagnosis of cervical cancer means it can be treated. Treatment is very successful when cervical cancer has been diagnosed early.
And since Gardasil doesn't protect against 30% of the cases of cervical cancer, "experts" still recommend regular PAP tests, anyway.
Seriously: don't fornicate/commit adultery, and get pap tests, and you're not going to die of cervical cancer!! I know people say "what if???" about rape, molestation, etc... but PAP tests can detect cervical cancer soon enough for it to be treated.
Posted by: Tammy L | February 23, 2007 5:13 PM
Amie,
They can make you - Texas forced a 13 year old girl to under chemotherapy even though she, and her parents, didn't want it for her.
I mentioned in my comment that I had to attend a class and get a notarized document for each child in order to exempt them from certain vaccines. The next day, social services showed up at my door to "check" on me. I had just moved in 3 days prior (our furniture hadn't even arrived yet!). Intimidation tactic? Yes!
The health department had called them and reported me for supposedly dropping my baby in the hallway (not true, she was in a stroller!)
(We happened to move in less than a week before school started, so I was scrambling to get the kids enrolled).
Posted by: Milehimama | February 23, 2007 5:24 PM
Ever tried not getting a pap smear? They don't like that either.
Posted by: ycw | February 24, 2007 3:31 PM
As the ecclesia, the called out ones, we are called to serve our communities wisely and humbly. Our example might be the early church that increased in number through it's bravery in caring for those, quite literally, left for dead. Early church workers took in babies abandoned because of sickness or deformities, they cared for contagious lepers. They cared for all manner of people that had contagious diseases that most people believed meant death. Due to the care of Christians, however, these people lived and became part of the church as well.
The church is at it's best when it seeks the best for the community in which it lives.
Someone mentioned earlier that vaccines are not 100% effective. That is true for any one individual; however, when entire communities are vaccinated the rate of infection plummets to almost zero. That is why even though certain vaccines can only be deemed 80% effective, they are almost a 100% effective in stopping the spread of diseases such as diptheria and whooping cough and polio. While you may not like the government intrusion of mandating the taking of vaccines, if you do not vaccinate your children your children are safer because of such a policy. To not take vaccines for religious reasons (and is that really the reason?) is to effectively become a parasite of the pagan community, drawing health benefits without contributing any of your own.
As to HPV in particular, I can see some differences. HPV is a sexually transmitted disease and I don't want my son or daughter to be sexually active until marriage. I waited, I expect them to do so as well; however, I know someone like me who was raped. I know a girl who is 12 that is pregnant. The father is 25. I know a woman who died of AIDS who was faithful to her husband. Cervical cancer will not be erradicated because the vaccine is 100% effective, it will be erradicated because when used by the entire society the effect is one of nearly 100%. What can we do with left over funding from the erradication of such a common disease. Will it mean increased research and funding for other cancers?
Lastly, I circumcised my son. Circumcision decreases his chances of being infected with an STD. We are often left to wonder why God gave Israel the laws He did. I do know that certain food and cleanliness laws provided health benefits for the community. Is circumcision one? Science says it cuts the risk of infection from STD by 1/3 for any individual, again, if everyone does it the risk of infection goes down. That is why circumcision is now being used to fight AIDS in Africa (BTW, sometimes a useful question to ask yourself is how would I react if I were in a third world country.) God values life and we communicate that to the world through fighting and preventing disease. Should doctors who are missionaries not vaccinate communities that are losing entire generations due to sexually communicated diseases? Having lost our lives already by giving them over to Christ are we not the best candidates for such a job?
I don't plan on handing out condoms to my children. But I'll be glad that the government requires me to vaccinate my daughter for HPV, and when she asks why she has to do it, I'll say we certainly do not expect her to ever be at risk for venereal disease because of what we have taught her, but we will submit to the government's authority on this one.
Posted by: Leslie | February 26, 2007 10:33 PM
Dear Leslie -
I don't usually have much time to respond to comments - though I read every one that comes in - because, well, because I always have so much other stuff to write about.
I do think your analogy of becoming parasites to the pagan community is interesting in a literary sort of way, but definitely way over the top and disrespectful to the real concerns that have been outlined by readers here.
Don't you live in Australia? I don't know what the situation there is, but the culture here in the States is clearly corrupted by the greed of the drug companies and dishonesty of our politicians. Merck has been caught using campaign contributions to influence at least one politician. Governor Perry of Texas used an EXECUTIVE ORDER - circumventing the legislative process - to mandate HPV vaccinations for preteen girls in Texas. That is a whopping misuse of power!! And Merck made a contribution to his campaign the same day. Do you see any reason to trust these people?
We have two threads going on this now, so be sure to read the comments at the other one. You are assuming this vaccine is safe. It has not been proven so and is being rushed through with unusual haste. Proponents trot out tales of young girls being raped (I was a victim at 8 myself), but how about a little thought about the Thalidomide disaster - remember, the safe sleeping pill for pregnant women that caused a generation of babies born missing important items like arms, legs, fingers and/or toes?
To compare what is necessary in Africa to what is necessary here is ridiculous. And by the way, my eight sons are not circumcised. Does that make me a worse mother than you? Or a parasite? No, it just means my huisband and I looked at both sides of the question and made a different decision. I would not mock yours or assume you to be more stupid than I - how about the same respect for those who disagree with you?
I'm happy you are able to get your daughter vaccinated if you wish to do so. No one has suggested taking away your right to make decisions on behalf of your daughter. And I don't appreciate your belittling the well-thought-out positions stated by many of my readers with ad hominem arguments which ignore the fact that many of us think this drug is not ready to be mass-marketed.
I agree with Tiffany, who stated on the other thread:
Here's the problem with Gardisil- HPV can't be spread to someone else during Algebra class. This isn't a health issue that the school system should be mandating. I'm not against the existence of such a vaccine, but it should be in the power of the patient to decide for themselves if they would like to take on that treatment. HPV is not being spread through school attendence. Period. So it should not be a requirement for school attendence. Period.
This is a parents' rights issue. It has an undercurrent of greed and corruption. It is another instance when Americans are being treated like sheep and not presented with all the facts, another instance where if you follow the money, you can't just blindly trust the guys in charge.
You can trust to the government's authority all you want, but who knows what parental rights they will take away from you next? And the question is, in our system of government in the United States, does our government have that authority? Remember, all authority is God-given, whether it is recognized as such or not. And we have a duty to keep our government as honest and accountable as possible.
Personally, I will submit to God's authority on this one - "Be wise as serpents and meek as doves."
Posted by: barbara | February 27, 2007 7:38 AM
You are right. Using the word parasite is over the top. I was wrong to use it. Please forgive me.
Posted by: Leslie | February 27, 2007 3:50 PM
okay I understand the controversy. I have three daughters ages 17,12 and 6. I have gotten them other vaccines. However , I truly object to this one. I dont believe that it has been tested long enough. It also isnt very effective. How can we stop our daughters from having to get it? The whole premise of the vaccine disturbs me.
Posted by: Monica | March 1, 2007 8:20 PM
How Dangerous Are Merck's Thought Police
By Pam Martens
According to an internal training manual, Merck, one of the largest pharmaceutical companies in the world and the maker of the controversial new vaccine for children, Gardasil, has a highly sophisticated sales group dedicated to "managing" the thoughts and voices of influential doctors in America; a de facto thought police. [*]
Gardasil is touted by the FDA and Merck as a vaccine to prevent cervical cancers associated with the sexually transmitted human papillomavirus (HPV). In the past few months, Merck has unleashed a firestorm of criticism when it was revealed that the company had funded a nonprofit group of state lawmakers, Women in Government, who were using their clout to get state legislation introduced across the country to mandate the vaccine for 11 and 12 year old school girls. The stated premise was that it would be most effective if given before girls became sexually active. Safety advocates countered that the vaccine's efficacy was never studied on this age population and clinical trials on safety issues were studied on just a few hundred 11 and 12 year old girls. Additional researchers have noted correctly that HPV related cervical lesions take 8 to 12 years or longer to develop into cervical cancer and since Merck only conducted clinical trials for 5 years or less, there is no conclusive evidence that this vaccine will prevent cervical cancer.
The thought police documents are part of a trove of confidential internal Merck marketing strategies demanded by Congress to determine how sales of Merck's last big blockbuster, Vioxx, continued to skyrocket in sales long after evidence of heart attacks and strokes emerged. The documents reveal an Orwellian marketing concept that goes like this: a team of "Specialty Representatives" gather intelligence on every aspect that motivates influential doctors in their assigned territories. Once this information is developed, these Merck intelligence officers narrow the data down to the key "drivers" of "beliefs and behaviors," then provide inducements to turn the doctors into "Advocates" for Merck products.
Merck has a revealing lexicon for this intelligence gathering and inducement strategy: influential doctors are called "thought leaders," and defined as doctors who, "due to their ability to influence their peers, drive therapeutic business at the national, regional or local level." The goal is clearly stated: "Understanding a thought leader's needs will assist you in developing a strong relationship with him/her and it will enable you to properly manage that advocate to create win-win situations for both Merck and the thought leader."
But not all thought leaders are created equal in the Kafkaesque world of Merck. "Once you understand the factors driving a thought leader's beliefs, behaviors, needs and patient management approaches, you'll want to determine their sphere of influence...These spheres of influence can be used to help you determine how to best manage a thought leader. There are three different classifications...Local Thought Leaders...Regional Thought Leaders...National Thought Leaders."
The National Thought Leaders are the jackpot for the thought police because they may "be driving the treatment approaches and methods on a national level" and "Typically, a national thought leader influences physicians at all levels across the nation."
Once the thought leaders have been studied, categorized and prioritized, the Merck thought police are to: "Determine how to interact with the thought leader; determine what activities the thought leader is best suited; how to best manage him/her based on this information."
Inducements to bring the thought leader on board as a Merck "Advocate" run the gamut of education grants, free travel to symposiums at resorts, a prestigious assignment as a clinical site investigator or a spot on the Merck Strategic Advisory Board.
Taken as a whole, the marketing plan attempts to provide strategic inducement to create a more sophisticated and influential extension of Merck's salaried sales force. That the public relies on its doctors for unbiased and unvarnished medical advice appears to be of no consequence to Merck.
And Merck is hardly alone. Industry watchers estimate that the pharmaceutical industry spends over $12 Billion a year under the dubious heading of marketing to doctors.
In Februrary 2007, a New York Times/CBS News poll found that 85 percent of survey participants thought it was "not acceptable" for doctors to be paid by drug companies to comment on prescription drugs and the same percentage said such payments would influence the decisions that doctors make about patient care.
At least one doctor has broken free of the Merck thought police recently on the issue of Gardasil. Dr. Diane Harper, a top level scientist and professor at Dartmouth Medical School in New Hampshire, has led clinical trials of the HPV vaccine and written widely on the topic. She is considered a pioneer in the field of HPV research and spent most of her adult life on this endeavor. Her work at Dartmouth is funded by both Merck and GlaxoSmithKline, which has its own HPV vaccine in the pipeline.
On March 14, 2007, in an article appearing in the Fort Wayne Daily News by Cindy Bevington, Dr. Harper is quoted as follows on the safety of Gardasil for young girls: "Giving it to 11-year-olds is a great big public health experiment...It is silly to mandate vaccination of 11- to 12-year-old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue...It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer -- they won't know for 25 years if they will get cervical cancer."
A week later, in an article by the same author, Dr. Harper attempted to soften her stance while not disputing that she made the earlier statements: "It is the mandate I am opposed to...For those parents and children who want the vaccine, it is safe - as we know from the bridging studies. We still don't know if it is effective for more than five years, though." The bridging studies Dr. Harper refers to means the safety outcomes in older pubescent women were assumed to be the same for prepubescent girls -- a leap of faith by any measure.
In fact, Dr. Harper could simply have quoted from the Food and Drug Administration (FDA) to document that safety had never been proven in 11 and 12 year old girls. As a condition of licensing Gardasil, the FDA acknowledged that inadequate safety studies had been done on this age population by stating in its June 8, 2006 approval letter to Merck: ââĤa sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008.â
In a breathtakingly reckless sweep of the pen, the FDA was licensing a product before a "sufficient" number of children had been studied to "permit an analysis of safety outcomes." Then the FDA sat back passively as Merck lobbied aggressively to get states to make the vaccine mandatory for 11 and 12 year old girls before these studies were completed.
While Merck has attempted to hide from public view its marketing tactics in the U.S., it has taken an openly brazen approach in Europe to push for Gardasil vaccination mandates through its European distributor and joint-venture partner, Sanofi Pasteur.
According to an article in The Guardian newspaper, quoting Angela Raffle, one of Britain's leading public health experts, "They wrote to every doctor of public health, every chief executive, every pharmacy adviser, senior people in the faculty of public health, all infectious disease specialists and primary care staff."
Thought leaders in Europe would be paid 1000 Pounds (equal to just under $2000 U.S.) to attend meetings where they would help "plan the introduction of the vaccine."
One such meeting was held in Paris. According to The Guardian, in addition to public health experts and celebrities, journalists were paid to attend. "A group of freelance health journalists from the U.K. had not only their travel, meals and accommodation but also their time paid for by the drug company."
The business model that clearly emerges at Merck is one where the infrastructure established to protect the public interest (doctors, public health experts, regulatory bodies and even journalists) must be sacrificed on the altar of corporate profits.
Merck's history of serial and systemic lapses of character and conscience demand that the left and the right of America stop sniping about peripheral issues raised by this vaccine and unite in debate on the overarching issue: has this drug been proven safe for little girls.
-------------
Pam Martens worked on Wall Street for 21 years and has been an activist for reform for the past ten years. She now writes on public interest issues from New Hampshire.
[*] See Document # 26: Merck, Specialty Foundations Participant Self-Study Workbook: Specialty Representative Advocate Development
http://oversight.house.gov/features/vioxx/documents.asp
Posted by: Pam Martens | April 16, 2007 3:58 PM
Gardisil is a manufactured vaccine, not a live viral vaccine. The vaccine has multiple benefits for girls and there is growing support to also vaccinate boys in the future as they are the source of the virus. morals/ethics/religion aside it is our duty as parents of young women to protect them as much as possible. what about nonconsensual sex? what if your virtuous daughter marries a man who has the virus? cervical cancer is an ugly form of cancer. who wouldn't want to protect their daughter from such a tragedy?
Posted by: barb | April 30, 2008 8:39 PM
