Gov. Rick Perry ordered Friday that schoolgirls in Texas must be vaccinated against the sexually transmitted virus that causes cervical cancer, making Texas the first state to require the shots. Breitbart.com

Your Comments, Thoughts, Questions, Ideas

stickdog's picture
stickdog says:

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 preteen 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 preteens 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 preteens 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 preteens 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.

posted on Mon, 02/05/2007 - 4:13am
Liza's picture
Liza says:

Stickdog,

You submitted several variations of this post to the website, so I'm randomly picking one to reply to.

You say,

”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.

Wow. Here are a few stats that might put this statement in perspective.
According to the Kinsey Institute:

  • A 2005 survey says that 26% of girls have had sex of some kind by age 15, 70% by 18, and 92% by 22-24. (Interestingly, and contrary to stereotype, these percentages are higher in every age bracket for girls than boys.)
  • The average age for first intercourse is 16.9 for boys and 17.4 for girls.
  • Among men ages 15-19, 62.2% reported sex with a single partner in the past 12 months, and 17.6% had 2 or more partners. 30.5% of women in the same age group reported a single partner, while 16.8% reported 2 or more.
  • A 1994 study revealed that 56% of American men and 30% of American women had 5 or more partners in their lifetime.
  • Further, a 2000 study showed that in one 7-month period, 16.6 out of 1000 college women experienced a rape, and 11 out of 1000 an attempted rape, for an overall rate of 2.8%.

According to a >2001 CDC “Youth Risk Behavior Survey”:

  • 6.6% of students had sex before age 13.
  • Of the 33.4% of “currently sexually active” students nationwide, only 57.9% reported that they or their partner had used a condom during last intercourse.
  • Further, male students (65.1%) were much more likely than female students (51.3%) to use condoms.

According to the CDC fact sheet on HPV:

  • 20 million people are currently infected with HPV.
  • At least 50% of sexually active people acquire genital HPV infection at some point in their lives.
  • By age 50, at least 80% of women will have acquired an HPV infection.
  • And 6.2 million Americans get a new HPV infection each year.

So…a majority of kids will have had sex of some kind, many with multiple partners, by the end of their high school careers, and only half of those girls are using condoms. Plus, you can catch HPV from your one and only lifetime sex partner if he or she has had others. There may be no symptoms, and there’s currently no way to test for HPV in boys. And not everyone is having consensual sex. Certainly makes vaccinating girls, who are the ones who “pay,” before they’re sexually active seem like a good idea to me…

You say,

”…It was not rigorously tested on [preteens] 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 preteens 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.”

I just want to clarify:
The vaccine was tested in over 11,000 women, ages 9-26, around the world, and those studies have shown no serious side effects. (The most common one is soreness at the injection site.)

Merck has also committed to a variety of long-term safety and efficacy studies.

As for “vaccine load,” children’s immune systems encounter literally thousands of challenges every single day. There is no reason whatsoever to delay or distribute vaccines instead of giving them according to the regular vaccine schedule.

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.

Gardasil is a “recombinant” vaccine, made through genetic engineering. In this case, the genes that code for a specific protein from each of the four virus types of HPV are expressed in yeast to create large quantities of the protein. The protein is purified and used to make the vaccine. Because the vaccine only contains a protein, and not the entire virus, the vaccine cannot cause the HPV infection. But the body's immune response to the recombinant protein(s) then protects against infection by the naturally occurring virus.

The FDA granted a license for the first recombinant vaccine—for hepatitis—to Chiron Corporation in 1986, so we have more than 20 years of data on their general safety and efficacy. We have more than five years of data on the Gardasil vaccine, with more studies in progress.

And we know that the protection offered by the vaccine lasts at least 4 years. More study is underway to see if boosters will be necessary.

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 preteens 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?

Four points:

  1. Teens and preteens may be more sexually active than you think. The numbers at the beginning of this post reflect that reality. And younger kids are more likely to engage in risky sexual behavior, so…
  2. According to a 2005 report on US Teen Sexual Activity by the Kaiser Family Foundation, "most (74%) sexually active females aged 15-19 have partners who are the same age or 1-3 years older; for a quarter of girls, their first partners were 4 or more years older. The younger a girl is when she has sex for the first time, the greater the average age difference is likely to be between her and her partner.... Teen girls with older male partners are more likely to be sexually active, less likely to use contraceptives...."
  3. Precancerous and cancerous lesions of the cervix are usually slow to develop. That’s why Pap smears are recommended every year for sexually active women under 30: dysplasias aren’t caught every time—it’s the repeated testing that’s likely to find the cancer. So it’s not really that surprising that the numbers of dysplasias and actual cancers caught in the four years of the study are low. The vaccine’s effect over a longer period of time is likely to be even more beneficial.
  4. You really seem to have a thing against sexually active women. So…girls that acquire HPV infections deserve it? And whatever happens to them, be it an uncomfortable treatment process that may have lasting impacts on fertility or an early death, is acceptable, even if it could have easily been prevented? What if it was your daughter who caught an HPV infection?

I TOTALLY agree, however, that the cost (and the availability) of the vaccine is an issue. And I'm not sure that HPV vaccination should be mandatory. I'll protect my own kids when I can, but until the cost can be brought down, I think the vaccine should be strongly recommended, and subsidized wherever possible, but not required.

“…Even if we place our hope in the fact that it might [reduce cervical cancer rates], cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.”

Worldwide, cervical cancer is the #2 cancer in women, causing over 470,000 new cases and 233,000 deaths each year. In the US, 9710 new cases of cervical cancer are diagnosed every year, and 3700 women die.

It’s true that cervical cancer is not one of the top-10 killers of women in the US (heart disease, stroke, lung cancer, respiratory diseases, Alzheimer’s, breast cancer, diabetes, accidents, flu/pneumonia, and colon cancer), but we don’t have vaccines for most of those, either. Surely you’re not saying we should abandon people to contract a preventable disease because other diseases kill more people? I have no problem requiring my children to get a flu shot, and as soon as my little girls are old enough, I’ll get them the HPV vaccine, too.

The vaccine doesn’t prevent against ALL strains of HPV that cause cancer. So Pap tests are still necessary. Pap tests are not very efficient—they detect precancerous lesions only 50-80% of the time, and cost billions of dollars each year. But cervical lesions are slow to become cancers: repeated yearly Pap tests will likely find them in time to treat them. (More than half of all cervical cancer deaths in the US are in women who don’t undergo screening, but 32% of women with cervical cancer surveyed in 2005 had had one or more normal Pap tests in the three years before the diagnosis.) And of the 50-60 million Pap tests done each year in the US, 2 million are classified as “ambiguous”—possibly precancerous, possibly not—and require further testing (usually a colposcopy and/or biopsy, which are expensive and uncomfortable). (New York Times, January 16, 2007)

And preteens and teens are actually not that likely to be getting annual Pap tests.

In one of your other entries (not posted, since it was essentially the same material) you wrote:

”2) HPV is a sexually communicable (not an infectious) virus.

I’m not sure what you mean when you say HPV is sexually communicable, but not infectious. The word “infectious" means:

  1. ”capable of spreading disease. Also known as communicable
  2. Capable of being transmitted from one individual to another, for example through sexual contact
  3. A disease capable of being transmitted by infection, with or without actual contact
  4. Capable of causing disease in a susceptible host.

Now I want to hear what OTHER Buzz visitors think. Should HPV vaccination be mandatory? Should the shots be given to children under 16? Do you have other worries or questions about the vaccine or the HPV virus itself?

posted on Mon, 02/05/2007 - 5:29pm
Lehua's picture
Lehua says:

Why isnt anyone talking about vaccinating boys as well? They are sexually active and spread HPV. The extent to which teens are sexually active is irrelevant because we know they are. California is seeing a spike in chlamydia rates for girls 15-18. We can expect that boys have similar rates, however because they are not receiving treatment at the same rate (if outward indicators are not present) it is not being detected at the same rate.

California is attempting to make the vaccine mandatory for girls, yet there are documented risks. If mandatory vaccination for boys was on the table as well, do you think legislators would be pushing it as hard?

When "mandatory" is attached to a vaccine that has not proven to be safe long-term, especially among young girls, it becomes a game of "lets see what happens." Everyone thought DES was safe for women in the 70's too, but we learned different at the expense of young girls and their reproductive system development.

The purpose of a vaccine is to eventually eradicate a disease. Preventing HPV and subsequent cervical cancer is obviously a good argument, however the HPV vaccine is being marketed as a "vaccine for cervical cancer," which is completely inaccurate. If we truly want to eradicate HPV, why are only girls being targeted? It would be like offering a herpes vaccination to only women.

posted on Tue, 04/10/2007 - 11:29am
Liza's picture
Liza says:

Well, let's start with the easy part:

The HPV vaccine is being recommended for women for a few good reasons:

  • While other cancers are possibly linked to HPV infection, we know for sure that certain strains of HPV are linked to cervical cancer. And cervical cancer, obviously, occurs only in women.
  • Only women participated in the large-scale safety and efficacy trials.

That said, the vaccine manufacturers are now considering licensing the vaccine for boys, too.

For my part, I think that if we were talking about a mandatory vaccine for all children instead of one licensed specifically to protect girls against a sexually-transmitted infection, there'd be a lot less fuss. I think most of the hype is for two reasons: a) the vaccine is expensive, and most of us don't want to see pharmaceutical companies siphoning money away from other pressing needs; and b) lots of folks are uncomfortable with the idea of unmarried women having sex.

posted on Wed, 04/11/2007 - 1:08pm
stickdog's picture
stickdog says:

I'm not trying to get in a discussion with you so much as educate you about all the issues concerning this vaccine.

What follows is what I am trying to tell you in full. Feel free to cherry pick whatever you want to make your points, but please understand that I'm not trying to argue with you but instead to inform you of facts and points that you may not have yet known or considered.

LIZA says: "Stickdog, the best education comes through discussion. I’m fairly sure that I can’t bring you around to my point of view, and you’re not likely to convince me of yours, but others reading this may find the discussion helpful. Also, I see that you’ve posted the same information, word-for-word, on a few anti-vaccine websites. (I certainly hope that these posts are at least written by you, and not plagiarized from somewhere else and plastered all over the Internet…)

Also, I didn’t “cherry pick” anything. I took one of your submissions and posted it unaltered. And then I responded to the things I took issue with. Other readers should feel free to do the same, to my posts OR yours.

Normally I don’t insert my own posts in the middle of someone else’s. But yours are so long that I feel I need to respond right there, where Buzz users will be reading."

What Every Parent With A Daughter Should Know About GARDASIL

1) GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.

LIZA says: "True."

2) HPV is a sexually communicable (not an infectious) virus. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four "bad ones" protected for in GARDASIL) results in no known health complications of any kind.

LIZA says: "You can say that my quibble here is a "semantic point," but you keep repeating it, and it doesn't make any sense. HPV IS infectious. And a huge number of people are infected. Yes, it spreads through sex. But it also spreads through skin-to-skin contact usually associated with sex although not necessarily limited to intercourse. A condom does help, but it does not eliminate the risk. (The CDC cannot estimate how much that risk is reduced, by the way.) The CDC also says: 'While most HPV types cause no symptoms and go away on their own, some types can cause cervical cancer in women. These types also have been linked to other less common genital cancers— including cancers of the anus, vagina, and vulva (area around the opening of the vagina). Other types of HPV can cause warts in the genital areas of men and women, called genital warts.'"

3) 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.

LIZA says: "Worldwide, cervical cancer is the #2 cancer in women, causing over 470,000 new cases and 233,000 deaths each year. In the US, 9710 new cases of cervical cancer are diagnosed every year, and 3700 women die.

It’s true that cervical cancer is not one of the top-10 killers of women in the US (heart disease, stroke, lung cancer, respiratory diseases, Alzheimer’s, breast cancer, diabetes, accidents, flu/pneumonia, and colon cancer), but we don’t have vaccines for most of those, either. Surely you’re not saying we should abandon people to contract a preventable disease because other diseases kill more people? I have no problem requiring my children to get a flu shot, and as soon as my little girls are old enough, I’ll get them the HPV vaccine, too.

The vaccine doesn’t prevent against ALL strains of HPV that cause cancer. So Pap tests are still necessary. Pap tests are not very efficient—they detect precancerous lesions only 50-80% of the time, and cost billions of dollars each year. But cervical lesions are slow to become cancers: repeated yearly Pap tests will likely find them in time to treat them. (More than half of all cervical cancer deaths in the US are in women who don’t undergo screening, but 32% of women with cervical cancer surveyed in 2005 had had one or more normal Pap tests in the three years before the diagnosis.) And of the 50-60 million Pap tests done each year in the US, 2 million are classified as 'ambiguous'—possibly precancerous, possibly not—and require further testing (usually a colposcopy and/or biopsy, which are expensive and uncomfortable). (New York Times, January 16, 2007)"

4) 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.

LIZA says: "The FDA does not share your concerns about the Merck study. Merck is, however, required to continue long-term study of the vaccine's safety and effectiveness.

When you talk about the aluminum salt adjuvant you are, I think, alluding to a paper called 'Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice,' which appeared in Neuromolecular Medicine, February 2007, Volume 9, Issue 1. (Lead author was MS Petrik.) The abstract of that article begins,

'Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene….'

This paper is specific to the anthrax vaccine, which was never recommended for widespread public use. And the HPV vaccine does not contain the adjuvants aluminum hydroxide and squalene. Instead, the HPV adjuvant is aluminum hydroxyphosphate sulfate. (Gardasil doesn’t include thimerosal or mercury, either.)

Alum is the most common adjuvant in vaccines. (In fact, aluminum salts, or alum, are the only adjuvant approved in the US for use in routine preventive vaccines.) Live vaccines, which contain weakened forms of infectious organisms, usually work just fine without adjuvants such as alum. But vaccines containing killed organisms (inactivated vaccines) or pieces of them or their toxins (acellular or recombinant vaccines, including the HPV vaccine), generally need adjuvants to boost their effectiveness.

The adjuvant has been included in vaccines given to hundreds of millions of people over eighty years. Alum was first widely used in the 1950s in the Salk poliomyelitis vaccine. Since then, it’s been included in the diptheria/tetanus/pertussis (DtaP), hepatitis, Haemophilus influenzae (Hib), typhoid, and some flu vaccines. Scientists have known for decades that adjuvants work, but they've only recently discovered the mechanism that explains how: Scientists at National Jewish Medical and Research Center discovered that it makes a group of immune-system cells to release interleukin-4, a protein that primes B cells for a better response to the vaccine. (06/18/2004 Science)"

5) 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.

LIZA says: "The data on adverse experiences, as well as the study protocol and results, are available on-line as part of Merck's information for patients and health care providers.

A 'myriad' of short term and medium term health problems? Let's see...pain (the most common side effect, with 83.9% of Gardasil recipients and 48.6% of 'true' placebo recipients reporting it), swelling, erhythema, pruitus, fever, nausea, and dizziness (the least reported vaccine-caused side effect, with 2.8% of Gardasil recipients and 2.6% of 'true' placebo recipients reporting it). Further, 94.3% of the Gardasil recipients describe their injection-site adverse experience to be 'mild or moderate in intensity.'

'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.

Deaths
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."

Hard to blame any of those things on a vaccine...

Lastly, of the 11,813 people who received Gardasil, a total of 9 reported an 'incident condition potentially indicative of systemic autoimmune disorder,' including juvenile arthritis, rheumatoid arthritis, systemic lupus erythematosus, arthritis, and reactive arthritis. 3 of the 9701 placebo recipients reported the same conditions."

6) 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.

LIZA says: "Precancerous and cancerous lesions of the cervix are usually slow to develop. That’s why Pap smears are recommended every year for sexually active women under 30: dysplasias aren’t caught every time—it’s the repeated testing that’s likely to find the cancer. So it’s not really that surprising that the numbers of dysplasias and actual cancers caught in the four years of the study are low. The vaccine’s effect over a longer period of time is likely to be even more beneficial."

7) 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.

LIZA says: "Long term safety and efficacy is currently being studied. But there is no reason to think that the effects on girls aged 11-12 (the target demographic) are any different than they are on women aged 16-26."

8) 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.

LIZA says: "It IS expensive. There's no doubt about that.

*****

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.

LIZA says: "A quick survey of literature on the HPV vaccine, both scholarly and popular, shows that most experts are optimistic."

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.

LIZA says: "Gardasil alone is not a panacea. Routine check-ups, including Pap tests, will continue to be necessary. I don't think that anyone is arguing otherwise."

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.

Liza says: "Again, you're generalizing from one single paper, recently published and as yet unreplicated, based on experimental studies in mice, not people, that focused on a different vaccine and a different adjuvant, to suggest that anyone who receives a vaccine with an aluminum salt adjuvant will experience neural death. It's a big leap, and it's bad science. Hundreds of millions of people have been given vaccines containing aluminum salt adjuvants for eight decades, and there just isn't any data to back up what you're suggesting."

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?

LIZA says: "Here we agree. I can't think of a reason to make the vaccine mandatory at this point. But I also can't think of a good reason not to strongly recommend it.

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.

LIZA says: "I think that you are overestimating the percentage of the at-risk population who receive annual Pap tests. Now I'm guessing, but I'd be willing to wager that the only preteen and young teen girls who are getting annual Pap tests are the few who are either a) completely open with their parents about sexual activity; or b) responsible enough to go to Planned Parenthood or some other clinic where they can afford their own care. Many young women are without health insurance, which means they skip out on preventive care. I would further wager that most of the women getting Pap tests on an annual basis are those taking oral contraceptives, since an annual visit to the OB/GYN is compulsory for getting a 1-year prescription renewed. Or those that have already experienced some kind of problem.

I agree with you, however, that Merck should make the vaccine more affordable and available, and the company is being pressured to do so."

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.

LIZA says, "I know of no pre-teens who are NOT sexually active who are receiving annual Pap tests.

The American Cancer Society recommends that Pap tests should start within 3 years of a woman beginning sexual intercourse, whatever age that may be, but no later than 21 years of age. From then on, women younger than 30 should have yearly Pap exams. And women older than 30 have screening recommendations based on their risk factors. (Women over 30 with no risk factors and a history of normal Paps are supposed to be screened every 2-3 years.)

Many women have annual Pap exams because prescriptions for the birth control pill generally last a year, and a woman needs an exam to get the prescription renewed. Pap tests are often part of these annual exams. But remember that not all women, especially women under 18, take oral contraceptives, so yearly Pap exams for teens are not at all a given. Especially when you consider that these women may not be 100% honest with their parents or medical providers about their sexual history, so the need for the Pap test may not be evident."

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.

LIZA says: "I agree with you 100% that this vaccine is most needed in the developing world. That's where it would have its biggest impact. But first-world nations are always the first to receive pharmaceuticals, at high cost, and these are generally available in the developing world only because of intense public pressure and commitment, or because the patents have run out. Gardasil is no different than any other vaccine or drug."

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.

LIZA says: "Check out this other Buzz thread about the HPV vaccine. You'll see that others (myself included) share your concern about the marketing of the vaccine. I still think it's a good thing, though."

posted on Mon, 02/05/2007 - 9:29pm
stickdog's picture
stickdog says:

To be clear, I am not here to pick nits with you. I am fully aware of every point you made, even the semantical one.

BTW, here are my sources --

Merck and the FDA: http://www.fda.gov/cber/label/hpvmer060806LB.htm

Also see, NY Times OP: http://tinyurl.com/2cyzsj

and

Scary new peer reviewed journal published study about alum injections causing neural death in mice:

http://www.straight.com/article/vaccines-show-sinister-side
http://tinyurl.com/3xhtdz

posted on Mon, 02/05/2007 - 9:34pm
Bizzeeb's picture
Bizzeeb says:

I recently had a hysterectomy which began with a diagnosis of carcinoma in situ of the cervix, and HPV was identified as present. Up until the point where the decision to have a hysterectomy was determined to be the best course of action for me, I had several rather unpleasant procedures to remove the recurring lesions.

Luckily I did not want children, and the decision to have the hysterectomy was a no-brainer. However I am sure for many women this would have been a devastating situation if they had their heart set on having a child. Even if the more conservative procedures had been successful, the cervix is compromised to a point while healing. Not to mention, what does a woman do if she becomes pregnant and in the course of followup treatments, the lesions recur?

I am sure there may be some small risk associated with the vaccine and currently we do not know how long the vaccine is effective for before a booster would be necessary. From my perspective, the risk of NOT having the vaccine is greater. And rather than speculate upon what sexual activity one may or may not be partaking of at a given age, my feeling is to err on the side of caution and administer the vaccine. I don't believe it is prudent to decline a measles vaccine because the 'likelihood' of actually encountering it in the U.S. is low. Why should this be treated any differently? Better to have it and not need it rather than to need it and not have it.

I truly don't recall this much hoopla over the nasal spray flu vaccine (then again nobody was mandating that anyone receive it). And I don't recall this degree of controversy over the varicella vaccine. Again, those were not issues that hit so close to home with me. Perhaps the unease with Gardasil goes back to, once again, personal feelings about morality and female sexuality. Did Viagra cause this much commotion? There are some potentially unpleasant side effects for that drug. Apparently enough men feel the benefit of that particular drug is worth the potential risks. And Viagra doesn't even prevent a disease that we know of.

Leave the probability of sexual activity and onset thereof, or abstinence out of the equation and return to pragmatism. Before mandating the vaccine, 2 items need to be made clear. 1) What trends are seen as potential side effects of receiving the vaccine and 2) How long is the vaccine effective before (If) a booster is needed. Until then, the parent needs to determine if they want their child vaccinated. If I had a child, there would be no question in my mind. Get the vaccination.

posted on Mon, 02/05/2007 - 10:41pm
Liza's picture
Liza says:

For more on the HPV vaccine, read this other Buzz thread.

posted on Tue, 02/06/2007 - 5:16pm
Gene's picture
Gene says:

This article looks at the issue from a purely financial standpoint. The cost of the vaccine per preventable death is very high. While it's great that individuals can have access to this treatment if they choose, should the state really be making this mandatory -- especially if that same money could have a greater impact if spent elsewhere?

What do you think?

posted on Sun, 02/11/2007 - 1:28pm
Liza's picture
Liza says:

The Minnesota legislature is debating whether or not vaccination with the HPV vaccine should be mandatory. Gardasil was also the topic of the first hour of today's Midmorning broadcast on MPR. (2/19/07) Guests included:

  • MN Rep. Karen Clark (DFL-Minneapolis), Chair of the Public Health Finance Committee and registered nurse;
  • MN Rep. Erin Murphy (DFL-St. Paul), member of the Health and Human Services Committee and registered nurse;
  • Former AP correspondent Arthur Allen, currently writing for Slate's "Medical Examiner" column and author of Vaccine: The Controversial Story of Medicine's Greatest Lifesaver.
posted on Mon, 02/19/2007 - 6:13pm
Liza's picture
Liza says:

Merck is putting on hold its lobbying campaign to make Gardasil vaccination mandatory.

Merck's medical director for vaccines, Dr. Richard M. Haupt, told the Associated Press:

"We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts."

The article continues,

"Dr. Anne Francis, who chairs an American Academy of Pediatrics committee that advocates for better insurer reimbursement on vaccines, called Merck's change of heart 'a good move for the public.'

'I believe that their timing was a little bit premature,' she said, 'so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects.

Given that the country has been 'burned' by some drugs whose serious side effects emerged only after they were in wide use, including Merck's withdrawn painkiller Vioxx, Francis said, it would be better to wait awhile before mandating Gardasil usage."

(I should note, though, that the American Academy of Pediatrics supports broad use of the vaccine.)

The National Vaccine Information Center, a group of parents worried that vaccines harm some children, have been publicizing reports of side effects associated with Gardasil vaccination: dizziness and fainting in several dozen people.

While I, too, am uncomfortable with the amount of lobbying power big pharmaceutical companies have, and with reports of less-than-scrupulously-ethical clinical trials, I think that most of the fuss about Gardasil has to do with two factors: its price (completely unaffordable for a lot of people), and the fact that it protects GIRLS against a sexually transmitted disease.

If the vaccine was $150 cheaper and protected against a disease transmitted differently, I bet we wouldn't even be having this conversation.

posted on Tue, 02/20/2007 - 9:13pm
Liza's picture
Liza says:

The CDC, in response to charges made by the National Vaccine Information Center, said Wednesday (2/21) that no additional warnings are needed for the Gardasil vaccine.

According to the Associated Press article,

"Many of the reports involved fainting, but teens tend to faint from vaccinations anyway, health experts said, and the number of cases doesn't exceed what was expected.

There also does not seem to be a worrisome association between the vaccine and Guillain-Barre syndrome, and there's no evidence that the vaccine isn't safe when given at the same time as other vaccines.

posted on Fri, 02/23/2007 - 3:00pm
Mr.JerryBanzor's picture
Mr.JerryBanzor says:

Hello,
Very Informative Posts.
I really like what you have going on here. I'll be back soon

posted on Wed, 04/18/2007 - 4:32pm

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