Most doctors are losing money over this, due to poor insurance reimbursement. At best, they break even. (via GruntDoc)
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I definitely see this happening in the peds clinics I work in. It’s sad, truly.
theanonymousmedicalstudent.blogspot.com
1) Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don’t get pap smears until after the cancer has existed for many years.
2) Merck’s clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the “placebo”) and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.
3) Both the “placebo” groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications — as in less than half. Furthermore, most if not all longer term complications were written off as not being potentially vaccine caused for all subjects.
4) Because the pool of test subjects was so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM — MUCH LESS DIED OF IT. Instead, this vaccine’s supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and “precancerous lesions” (dysplasias) than the alum injected “control” subjects.
5) Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.
6) GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck’s biggest cash cow of this and the next decade.
These are simply the facts of the situation as presented by Merck and the FDA.
Wah. if you are losing money on something then stop selling it. What’s the problem?
Stickdog, interesting info. I am really have only purely academic interest in the matter since I am not a doctor, don’t have daughters and am not young. Still it kind of bugs me that a governor of Texas wants to make it mandatory for Texas schoolgirls.
I am all for vaccines, but is the governor of Texas qualified to make this type of decisions?
The family discussions about vaccinating girls as young as 9 years of age with Gardasil will be interesting.
Are we getting prepped for the middle school and high school years?
“I am all for vaccines, but is the governor of Texas qualified to make this type of decisions?”
Absolutely not. The issue is whether cevical cancer is a public health problem and who should pay for the vaccine. What is next, mandatory birth control pills/Norplant/IUD as a condition of attending school?
There are two sides to every discussion, of course. This vaccine does appear to confer some benefits. If I were a sexually active woman who disliked condoms and liked to have multiple sex partners who had not yet been exposed to any of the four strains of HPV that this vaccine protects against, I just might sign myself up.
But that’s not the same thing as making this vaccine MANDATORY for a pre-teen population it was not rigorously tested on a scant 8 months after its initial rush job FDA approval.
Aside from all the known risks of all vaccines, the unknown risks of this three shot regimen for pre-teens along with their other vaccine load, and the unknown long term risks of this vaccine for all populations, we have to look at cost vs. benefit.
7861 of the placebo subjects contracted 83 cases of HPV 6-, 11-, 16-, 18-related dysplasias during the testing period compared compared to 4 cases among the 7858 subjects who were given GARDASIL. That’s after counting out every subject with any prior exposure to these strains. This includes 42 of the less serious HPV 6-, 11- related low grade dysplasias.
Merck has published no data for how many non-HPV 6-, 11-, 16-, 18-related dysplasias were contracted by these subjects over these periods, but some practitioners have commented that they expect the vaccine to protect against 40%-50% of all dysplasias.
In terms of every possible kind of dysplasia for which this vaccine confers protection, Merck’s own clinical evidence suggests that this vaccine saved about 10 patients out of each 1000 injected from the painful process of having these dysplasias treated (over the entire course of follow ups which ranged from 18 months to 4 years). Note that the populations for these studies were not pre-teens but women at the height of their sexual activity. Further note that since the vaccine uses virus-like particles (a new vaccine technology) and is only about five years in testing now, there is no guarantee that it has any long term efficacy.
Of course, the pre-teen population is so less sexually active (and when active, so much less likely to be active with a previously contaminated partner) that I think it would be conservative to estimate that pre-teens are 5 times less likely to contract HPV dysplasias than the 16 to 26 year olds who were tested by Merck. So instead of saving 10 women per 1000 from painful treatments for HPV dysplasias, this vaccine would save perhaps 2 girls per 1000 from these procedures among the much younger population that Merck and Merck’s politicians are targeting for mandatory vaccination.
Do we really want to pursue a public policy that costs $360,000 to vaccinate every 1000 girls while exposing each and every one of these thousand girls to the known adverse short term and largely unknown long terms side effects of three injections of a new vaccine just to save two of the more sexually active of these kids from having to have their dysplasias treated conventionally?
What kind of a risk and cost vs. benefit trade off is that?
Note that nowhere are we discussing actual incidences of cervical cancer because there is no clinical evidence whatsoever that GARDASIL reduces cervical cancer rates, and even if we place our hope in the the fact that it might, cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.
*****
While it is a widely accepted medical theory that HPV “causes” cervical cancer, it’s not close to being a fact. Although the vast majority do, many cases of cervical cancer don’t show any association with HPV. It’s a very good guess that certain strains of HPV are necessary co-factors for certain highly prevalent types of cervical cancer to emerge. The two really bad strains protected for in GARDASIL go hand in hand with 70% of CURRENT cervical cancer cases. My point is that there are 36 nasty strains of HPV screened for currently, and the human body is an ecology. We have no idea how protection against the two strains of HPV that are CURRENTLY most prevalently associated with cervical cancer (typically decades after initial exposure) will affect overall cervical cancer rates far in the future.
What we instead DO know is that current practices of annual pap smears and screening for ALL bad strains of HPV continue to reduce rates of cervical cancer among the US population annually. If all US women received a pap smear every year and were then promptly treated for any abnormal growths encountered, both the cervical cancer contraction and mortality rates would plummet even further to the point where HPV-associated cervical cancer would kill no more than a handful of US women a year. Yes, that is a guess as well, but it’s a far better guess than assuming that conferring protection against four of the myriad of current and future strains of harmful HPV will somehow do the trick.
Certainly GARDASIL’s benefit data against the four strains of HPV it targets are compelling. HOWEVER, the benefit data against ALL forms of HPV are not published by Merck and estimated by OP-GYNs to be a mixed bag. The benefit data against cervical cancer itself are nonexistent. The long term risk data for any population are nonexistent. There are almost no risk data at all for pre-teens. The fact that the “placebo control” was a shot of alum that was recently shown to cause neural death in mice is particularly problematic in terms of interpreting the small amount of risk data that were gathered.
Studies of the long-term benefits of a new drug or vaccine take a long time. It would take several decades to prove conclusively that this vaccine prevents cervical cancer deaths. So why the rush to make these three injections COMPULSORY for pre-teens?
Perhaps this would be excusable if GARDASIL conferred protection against HPV generally, but it does not. We have absolutely no way of even guessing how conferring protection against four strains of HPV will affect cervical cancer rates decades down the line. If you think you do, then please quantify the expected benefits in terms of the expected reduction of cervical cancer contraction and mortality rates for the population of US women who get annual pap smears. The only thing you can say about these numbers are that they are both unknown and tiny.
*****
I am not trying to stop anyone from signing up themselves or their kids for this. If you want to pay $360 to make your little girl one of Merck’s test subjects, please do. As I said, the vaccine shows promise. It may be a life saver for a small segment of the population (especially those too poor or uninformed to get annual pap smears), and it offers protection against most genital warts and a good percentage of HPV dysplasias. The procedures to remove these warts and dysplasias are very painful, so these benefits are compelling. However, the risk and cost vs. benefit profile of this vaccine is not such that it is good public policy to mandate it — especially not for a pre-teen population on which it has never been sufficiently tested — even with an “opt out” clause. If Merck wants to make sure that women and parents who want it and can’t afford it can get it, they should offer it to low income individuals and families on a sliding scale rather than lobbying state and federal governments to pony up the billions.
This is hope-based medical policy. We are hoping the vaccine will have benefits against cervical cancer, and we are hoping that three injections of this vaccine (along with its alum adjuvant) will have no meaningful long term effects. We are talking about forcing a vaccine with a completely unknown period of efficacy on a pre-teen population it was not tested on — most of whom already get annual pap smears despite no or limited sexual activity! How many among the population of 9 to 26 year old women who get annual pap smears die of cervical cancer? This number is TINY and always getting smaller as we screen for more and strains of HPV.
You know who could really use this vaccine? Places where you can’t go down to the women’s needs center to get your annual pap smear. Places where they can’t afford to effectively treat dysplasias. Places like the third world. But Merck needs money after its VIOXX disaster, so our daughters are being made into the guinea pigs for this vaccine so Merck can rob our public coffers.
In terms of genital warts, that’s actually what this vaccine has been shown to be highly effective against. If Merck wants to sell it to women and men that way, I have no problem with that. But you should have to opt in rather than have it forced on your kids by Big Brother as a condition of sending them middle school! Now we see that all these commercials had little to do with actually selling the product to us, but were instead all about selling the idea to us that it would be a good thing to make this vaccine mandatory.
Hi, I got the first shot of the gardasil vaccine and after doing research, have decided not to get the next two. Is this going to cause any adverse side effects? Also, does gardasil affect fertility?
I was told by my doctor that there weren’t any side affects on fertility, but he also refused to answer my questions about what happens when I don’t get the next two shots which is a big concern for me. I want to have children some day and I want to make the best decision now for my future.
My daughter got the first shot on Friday and we spent Saturday in the ER. While it is doubtful her shaking, severe abdominal pain, vomiting, and sweating were all related to the vaccine the 3″ x 4″ goose-egg on her arm is. She is also having shoulder pain, and shooting pain down her arm. I will be taking her to the doctor tomorrow. I am worried that the nurse injected into the subcutaneous tissue since she didn’t even inject in the deltoid and I can’t find any info on the effects of this drug when given improperly. This was my daughter’s first and LAST injection of this drug!!!
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