Australia’s Therapeutic Goods Administration (TGA), roughly the equivalent of the United States’ FDA, has approved the Gardasil vaccine for use by women up to age 45. Previously, it had been approved only for ages 9-26. The vaccine was developed by Professor Ian Frazer, who was named Australian of the Year in 2006.
Earlier this year the FDA refused to allow Gardasil to be used in older women, citing the need for completion of an ongoing 48-month study and an analysis of the data.
The FDA’s caution may well spring from background information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) back in May 2006. The Committee was extremely concerned about data that showed that when the vaccine is given to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a startling 44.6 percent. The vaccine does not clear existing infections.
The TGA’s decision was likely spurred by a recent Columbian study funded by Gardasil maker Merck. It found that the vaccine was 91 percent effective in preventing new infections in women aged 24-45 if—and this is a big 'if'—they had never previously had HPV or cervical disease. The Australian public health service will not provide the vaccine free of charge for women under or over the ages of 12-26 as it clearly is not cost-effective, recommending instead that women continue to be vigilant about getting regular Pap smears.
Gardasil protects against two cancer-causing strains and two genital-wart causing strains of human papillomavirus (HPV). There are thought to be more than 100 strains of HPV, about 40 of which can cause cancer, and about 80 percent of the population will be infected with it at some point in their life. Some 95 percent of infections are shrugged off by the body within about 18 months, leaving a natural immunity to that strain. Only persistent infections can cause the lesions that might eventually become cervical cancer. Most lesions are easily detected during an annual Pap smear test in developed nations, although cervical cancer is a major killer in some countries where women do not have access to routine health care.
Showing posts with label HPV. Show all posts
Showing posts with label HPV. Show all posts
Tuesday, August 4, 2009
Thursday, July 30, 2009
Pap Smears for Young Women: A Waste of Time and Money—or Not?
A new study from Queen Mary College, London, has found that Pap testing for sexually active young women may not be such a good idea—in fact “doing more harm than good.” But there are a few caveats that women might want to consider before following standard one-size-fits-all advice.
The researchers, curious about the effectiveness of aggressive treatment for low-grade lesions that often heal themselves in young women, compared 4,012 women aged 20-69 who had been diagnosed with cervical cancer with a matched group of 7,889 cancer-free women.
The study found three things:
· The outcome was no different for young women with abnormal cells whether they received a colposcopy—a microscopic examination of the cervix, possibly including a biopsy of suspicious cells—or whether they were told to come back later for more testing. Pap screenings didn’t reduce cervical cancer incidence over the next five years for women aged 22-24, but there was a 43-60 percent reduction in incidence for women aged 30-37.
· There was no difference in outcome for women who had a colposcopy and excision of abnormal cells and those who didn’t, although the surgical group suffered more problems such as bleeding.
· Immediate colposcopys did not prove any more cost-effective than ‘watchful waiting.’
“When you look at the balance of benefits and harms, surveillance does as well,” said Eduardo Franco, a professor of epidemiology and oncology who co-authored an editorial about the study in the British Medical Journal.
England’s recent policy of offering Pap smears only to women over 25 (women in Scotland, Wales and Northern Ireland can still get them at age 20) has been under fire ever since the furor over reality TV star Jade Goody’s untimely death from cervical cancer at the age of 27.
Goody’s tearful phone call with a doctor telling her she had cancer, on-camera during Big Brother filming, has been viewed millions of times over the internet. The progression of her illness—the cancer had metastasized to her bowel, liver and groin—was followed by a horrified international audience and there was an unprecedented rush for Pap smears in the UK. The surge in requests became known as ‘the Jade Goody effect.’
English health officials maintained that the new 25-and-over policy followed guidelines set by the International Agency for Research on Cancer. Cervical cancer in under-25s is extremely rare, officials said, but changes in the cervix are very common. Screening at 20 could therefore result in unnecessary interventions that could, indeed, do more harm than good. The new study appears to bear out this belief.
Currently women in the US are advised to begin screenings within three years of starting sexual activity or upon turning 21, whichever comes first. The American Cancer Society is considering revising its guidelines because of the Queen Mary College study.
But here’s what you should think about.
One size doesn’t always fit all. Although a huge percentage of tests and procedures in the US are known to be unnecessary and it’s important to rein in costs, as an individual you need to make informed choices. While raising the blanket testing age to 21 may well make sense, you yourself have to be totally and completely honest with your gynecologist about your personal life, including:
· Number of sexual partners. The more partners you have, the more varieties of the HPV virus (that causes most cases of cervical cancer) you will be exposed to. Studies have shown that people with more sexual partners are more likely to get cervical, anal and oral cancers. Young girls are particularly vulnerable to HPV because cervical cells are unstable and changing rapidly; protective cervical mucous is also not being produced as efficiently as in later years.
· Smoking. Smokers are 14 to 27 times (times, not percent) more likely to develop pre-cancerous lesions than non-smokers.
· Diet. People with a diet high in vegetables and fruits are at least 50 percent less likely to develop pre-cancerous lesions.
If your gynecologist doesn’t ask you about these issues, it’s up to you to bring them up and ask whether you should get earlier testing, plus HPV testing, if you have higher risks. You should also be aware that in Britain, at least, the incidence of cases of the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004, suggesting that either HPV is becoming nastier or risky habits are making younger women more vulnerable.
If you and your gynecologist do decide on delaying testing to, or on ‘watchful waiting’—according to the study, possibly a better option if testing detects pre-cancerous cells—try to make healthy lifestyle choices such as quitting smoking if you smoke and including lots of vegetables and fruits in your diet. These changes will help to bolster your immune system so that you can shake off HPV.
One last caveat: don’t think you’re safe if you’ve had the Gardasil vaccine against HPV. It protects against only four HPV viruses out of more than 100, at least 40 of which are known to be cancer-causing, and has proved to be 17-45 percent effective against pre-cancerous lesions. Its eventual effectiveness against cervical cancer is still unknown and replacement disease, where other strains of the virus fill the void left by vanquished strains, is a real possibility. Don’t forgo your annual visit to your gynecologist, and above all, be honest when you do go.
The researchers, curious about the effectiveness of aggressive treatment for low-grade lesions that often heal themselves in young women, compared 4,012 women aged 20-69 who had been diagnosed with cervical cancer with a matched group of 7,889 cancer-free women.
The study found three things:
· The outcome was no different for young women with abnormal cells whether they received a colposcopy—a microscopic examination of the cervix, possibly including a biopsy of suspicious cells—or whether they were told to come back later for more testing. Pap screenings didn’t reduce cervical cancer incidence over the next five years for women aged 22-24, but there was a 43-60 percent reduction in incidence for women aged 30-37.
· There was no difference in outcome for women who had a colposcopy and excision of abnormal cells and those who didn’t, although the surgical group suffered more problems such as bleeding.
· Immediate colposcopys did not prove any more cost-effective than ‘watchful waiting.’
“When you look at the balance of benefits and harms, surveillance does as well,” said Eduardo Franco, a professor of epidemiology and oncology who co-authored an editorial about the study in the British Medical Journal.
England’s recent policy of offering Pap smears only to women over 25 (women in Scotland, Wales and Northern Ireland can still get them at age 20) has been under fire ever since the furor over reality TV star Jade Goody’s untimely death from cervical cancer at the age of 27.
Goody’s tearful phone call with a doctor telling her she had cancer, on-camera during Big Brother filming, has been viewed millions of times over the internet. The progression of her illness—the cancer had metastasized to her bowel, liver and groin—was followed by a horrified international audience and there was an unprecedented rush for Pap smears in the UK. The surge in requests became known as ‘the Jade Goody effect.’
English health officials maintained that the new 25-and-over policy followed guidelines set by the International Agency for Research on Cancer. Cervical cancer in under-25s is extremely rare, officials said, but changes in the cervix are very common. Screening at 20 could therefore result in unnecessary interventions that could, indeed, do more harm than good. The new study appears to bear out this belief.
Currently women in the US are advised to begin screenings within three years of starting sexual activity or upon turning 21, whichever comes first. The American Cancer Society is considering revising its guidelines because of the Queen Mary College study.
But here’s what you should think about.
One size doesn’t always fit all. Although a huge percentage of tests and procedures in the US are known to be unnecessary and it’s important to rein in costs, as an individual you need to make informed choices. While raising the blanket testing age to 21 may well make sense, you yourself have to be totally and completely honest with your gynecologist about your personal life, including:
· Number of sexual partners. The more partners you have, the more varieties of the HPV virus (that causes most cases of cervical cancer) you will be exposed to. Studies have shown that people with more sexual partners are more likely to get cervical, anal and oral cancers. Young girls are particularly vulnerable to HPV because cervical cells are unstable and changing rapidly; protective cervical mucous is also not being produced as efficiently as in later years.
· Smoking. Smokers are 14 to 27 times (times, not percent) more likely to develop pre-cancerous lesions than non-smokers.
· Diet. People with a diet high in vegetables and fruits are at least 50 percent less likely to develop pre-cancerous lesions.
If your gynecologist doesn’t ask you about these issues, it’s up to you to bring them up and ask whether you should get earlier testing, plus HPV testing, if you have higher risks. You should also be aware that in Britain, at least, the incidence of cases of the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004, suggesting that either HPV is becoming nastier or risky habits are making younger women more vulnerable.
If you and your gynecologist do decide on delaying testing to, or on ‘watchful waiting’—according to the study, possibly a better option if testing detects pre-cancerous cells—try to make healthy lifestyle choices such as quitting smoking if you smoke and including lots of vegetables and fruits in your diet. These changes will help to bolster your immune system so that you can shake off HPV.
One last caveat: don’t think you’re safe if you’ve had the Gardasil vaccine against HPV. It protects against only four HPV viruses out of more than 100, at least 40 of which are known to be cancer-causing, and has proved to be 17-45 percent effective against pre-cancerous lesions. Its eventual effectiveness against cervical cancer is still unknown and replacement disease, where other strains of the virus fill the void left by vanquished strains, is a real possibility. Don’t forgo your annual visit to your gynecologist, and above all, be honest when you do go.
Wednesday, July 22, 2009
How to Make Gardasil Side Effects Disappear
Since Gardasil made its debut, 15,716 suspected and actual side effects of the HPV vaccine have been reported to VAERS, our oh-so-fallible watchdog system. Just 15,716 bad reactions to who knows how many millions of vaccinations given—statistically insignificant, one might say, especially since so many were minor. Pain at the injection site, perhaps, or a little fainting spell.
The 736 suspected serious Gardasil side effects to date include 24 deaths, 147 life-threatening reactions, 255 permanent disabilities, 496 hospitalizations, 127 prolonged hospitalizations, and 544 emergency room visits.
And of course it’s important to remember that just because a report has been made to VAERS, that doesn’t mean the connection with Gardasil has been proven. In fact, some of the deaths almost certainly weren’t connected. It’s just as important to note that the system is notoriously fallible and that as few as one in ten reactions are reported, perhaps in part because information sheets handed to parents guide them to make a VAERS report only in the case of an immediate allergic reaction; there’s no mention at all of more subtle reactions.
But still, statistically insignificant.
Unless you think about the lesson we learned—or should have learned—from a doctoral student’s refinement of her thesis advisor’s study.
Remember that scandal, just a few years back? Harvard’s Dr. Chester Douglass took a research grant from the NIEH to study the possibility that fluoride in our water supply could cause osteosarcoma, a very rare bone cancer usually resulting in amputation or death. Douglass looked at 139 males and females with osteosarcoma and 280 matched controls, all of whom drank fluoridated tap water, and duly reported back that nope, there was no problem. Statistically speaking. Unfortunately for him he quoted a thesis study by Elise Bassin, his graduate student, as if it supported his conclusions. The thesis itself, though, was mysteriously unavailable to health researchers.
Eventually some terriers from the Environmental Working Group obtained limited access. And discovered that smart Elise had worked a lot harder and a lot more intelligently than her professor. Theorizing that children are much more likely to be susceptible to any harmful effects of fluoride at a time when their bones are growing rapidly, she focused only on the under-20s and their matched controls, and furthermore verified fluoride levels in the tap water drunk by all the children for each year in their lives, rather than just looking at the water they were drinking at the time of the study.
I won’t overload you with the details of her very plausible theory. The end result, however, was that yes, according to her study fluoridated water indeed appeared to raise the (tiny) risk of osteosarcoma in young males by 500 to 700 percent, with a particular risk between the ages of 6 and 8. Certainly a very different conclusion from that reached by Douglass, who moonlighted as editor-in-chief of the Colgate Oral Report and who chose to merge the statistics into the general population.
So back to Gardasil. If you look at the VAERS numbers with a traditional view to collateral damage, i.e. that a) a few will necessarily suffer for the greater good and b) numbers for nasties like motor neurone disease aren’t really all that different from what you might reasonably expect in the general population, then you probably see no cause to study Gardasil any further. You can make the side effects effectively disappear. by merging them into the general population.
But if you look at people rather than statistics; if you’re one of the young women affected, or the parent of one, you might wish like hell that you had an Elise Bassin looking at these happy statistics and applying a curious mind to them.
A curious scientific mind might look, for instance, at 97 cases of arthralgia, 4 of rheumatoid arthritis, 4 of juvenile arthritis and 3 of arthritis reported to VAERS, plus 2 cases of rheumatoid arthritis, 5 of arthritis, 1 of reactive arthritis, and 1 of juvenile arthritis seen in Merck’s initial study—a three-fold increase over the controls, who also received the aluminum-containing adjuvant—and wonder if these girls came from a subset. A subset of some kind that required only an environmental trigger, such as a vaccine, to wreak havoc on young bodies. Find the subset and you find a future group that should avoid Gardasil, that would be the way a Bassin-style mind would look at it.
A read through the VAERS reports suggests all kinds of subsets that should be studied by someone with a fine and open mind, someone who’s willing to put in the time to get exhaustive histories from these girls. Someone who might look at Jenny Tetlock’s devastating bout with extraordinarily rapid-onset ALS-like symptoms—the symptoms that killed her at 13—and at the two Gardasil girls just like her, and be consumed with the desire to know about any common factors and how they might have made those girls vulnerable. Someone who might study 68 reported cases of convulsions and 11 of epilepsy. Who might put out a call for similar cases in the general population, cases that went unreported just as the two ALS-type cases like Tetlock’s went unreported until her parents put up a blog.
Who might wonder why so many different immune diseases appear to be triggered by Gardasil, and instead of saying “Statistically, it doesn’t merit studying” would say “Damn, I just have to figure this out, so that we know which girls shouldn’t get the vaccine in future.”
We can make potential side effects statistically disappear alright. But we shouldn’t want to.
The 736 suspected serious Gardasil side effects to date include 24 deaths, 147 life-threatening reactions, 255 permanent disabilities, 496 hospitalizations, 127 prolonged hospitalizations, and 544 emergency room visits.
And of course it’s important to remember that just because a report has been made to VAERS, that doesn’t mean the connection with Gardasil has been proven. In fact, some of the deaths almost certainly weren’t connected. It’s just as important to note that the system is notoriously fallible and that as few as one in ten reactions are reported, perhaps in part because information sheets handed to parents guide them to make a VAERS report only in the case of an immediate allergic reaction; there’s no mention at all of more subtle reactions.
But still, statistically insignificant.
Unless you think about the lesson we learned—or should have learned—from a doctoral student’s refinement of her thesis advisor’s study.
Remember that scandal, just a few years back? Harvard’s Dr. Chester Douglass took a research grant from the NIEH to study the possibility that fluoride in our water supply could cause osteosarcoma, a very rare bone cancer usually resulting in amputation or death. Douglass looked at 139 males and females with osteosarcoma and 280 matched controls, all of whom drank fluoridated tap water, and duly reported back that nope, there was no problem. Statistically speaking. Unfortunately for him he quoted a thesis study by Elise Bassin, his graduate student, as if it supported his conclusions. The thesis itself, though, was mysteriously unavailable to health researchers.
Eventually some terriers from the Environmental Working Group obtained limited access. And discovered that smart Elise had worked a lot harder and a lot more intelligently than her professor. Theorizing that children are much more likely to be susceptible to any harmful effects of fluoride at a time when their bones are growing rapidly, she focused only on the under-20s and their matched controls, and furthermore verified fluoride levels in the tap water drunk by all the children for each year in their lives, rather than just looking at the water they were drinking at the time of the study.
I won’t overload you with the details of her very plausible theory. The end result, however, was that yes, according to her study fluoridated water indeed appeared to raise the (tiny) risk of osteosarcoma in young males by 500 to 700 percent, with a particular risk between the ages of 6 and 8. Certainly a very different conclusion from that reached by Douglass, who moonlighted as editor-in-chief of the Colgate Oral Report and who chose to merge the statistics into the general population.
So back to Gardasil. If you look at the VAERS numbers with a traditional view to collateral damage, i.e. that a) a few will necessarily suffer for the greater good and b) numbers for nasties like motor neurone disease aren’t really all that different from what you might reasonably expect in the general population, then you probably see no cause to study Gardasil any further. You can make the side effects effectively disappear. by merging them into the general population.
But if you look at people rather than statistics; if you’re one of the young women affected, or the parent of one, you might wish like hell that you had an Elise Bassin looking at these happy statistics and applying a curious mind to them.
A curious scientific mind might look, for instance, at 97 cases of arthralgia, 4 of rheumatoid arthritis, 4 of juvenile arthritis and 3 of arthritis reported to VAERS, plus 2 cases of rheumatoid arthritis, 5 of arthritis, 1 of reactive arthritis, and 1 of juvenile arthritis seen in Merck’s initial study—a three-fold increase over the controls, who also received the aluminum-containing adjuvant—and wonder if these girls came from a subset. A subset of some kind that required only an environmental trigger, such as a vaccine, to wreak havoc on young bodies. Find the subset and you find a future group that should avoid Gardasil, that would be the way a Bassin-style mind would look at it.
A read through the VAERS reports suggests all kinds of subsets that should be studied by someone with a fine and open mind, someone who’s willing to put in the time to get exhaustive histories from these girls. Someone who might look at Jenny Tetlock’s devastating bout with extraordinarily rapid-onset ALS-like symptoms—the symptoms that killed her at 13—and at the two Gardasil girls just like her, and be consumed with the desire to know about any common factors and how they might have made those girls vulnerable. Someone who might study 68 reported cases of convulsions and 11 of epilepsy. Who might put out a call for similar cases in the general population, cases that went unreported just as the two ALS-type cases like Tetlock’s went unreported until her parents put up a blog.
Who might wonder why so many different immune diseases appear to be triggered by Gardasil, and instead of saying “Statistically, it doesn’t merit studying” would say “Damn, I just have to figure this out, so that we know which girls shouldn’t get the vaccine in future.”
We can make potential side effects statistically disappear alright. But we shouldn’t want to.
Wednesday, July 15, 2009
So Why ARE Gardasil Girls Suffering Fainting and Syncope?
You knew it would happen just as soon as the FDA asked for an upgraded warning on Gardasil package inserts, drily explaining that an awful lot of girls seem to be fainting after their HPV vaccinations, and wouldn’t it be rather a good idea to monitor them and make them sit down. What with the possibility of suffering grievous injuries and all.
Well, duh.
But right on cue, here come the usually male-generated media and blog comments about how teenage girls faint all over the place anyway. Couldn’t possibly because of this particular vaccine. Here’s a typical comment:
“Now ask yourself: If you line up a bunch of giddy 13-year-old girls for an injection that has something to do with sex, cancer and genital warts, would you expect more or fewer than 2 in 10,000 to faint during the process?” The writer goes on to jokingly (one assumes) wonder whether Gardasil isn’t actually preventing mass fainting.
I don’t think I’ve heard a man wonder out loud whether the mention of sex—faugh, Sir!—wouldn’t make a woman faint since I read a cartload of 19th century novels in college a few decades ago.
Can there really be people out there who are unaware that the average 13-year old (and indeed the average 11 or 12 year old) is not only quite au fait with the oh-so-shivery idea of sex but, sadly, might even be quite practiced in the art of doing various unspeakable things? And that these kids have obligingly held out their arms to get stuck many, many times since infancy, usually without even asking what the damn needle is for?
Trust me, that’s not why they’re fainting. Even Merck is prepared to admit that the genetically-engineered ‘virus-like particles’ (VLPs) in this novel type of vaccine might have something to do with both the fainting and with the more severe and longer-lasting pain associated with Gardasil.
My own 16-year old has an almost pathological fear of needles. My ultimate threat when she breaks curfew is an acupuncture appointment (I know, but it’ll give her lots to talk about when she’s in therapy later). As a six year-old she actually bit the doctor who tried to give her an MMR booster, and last year literally back backed away like a startled horse over a truly fearsome shot being given her in preparation for a trip to India.
But she has never, not once, come even remotely close to fainting.
I’ll grant you that adolescent girls are more likely to be on faint-worthy crash diets than toddlers, so let’s look at the numbers reported to VAERS, the notoriously fallible vaccine adverse event reporting system. We’ll compare them to the numbers for Menactra, since it’s given to roughly the same crash-dieting teenage crowd.
2,172 girls have suffered syncope after being given the Gardasil vaccine. Out of 463 teens who’ve suffered syncope after the Menactra vaccine, 389 were girls and 6 sex unknown.
So roughly five and a half times as many girls have fainted after receiving the Gardasil vaccine as after Menactra, and Menactra has been on offer for about a year and a half longer than Gardasil, which went on sale in 2006, and is routinely given to both boys and girls. (Compare that to the chicken pox vaccine, part of vaccination programs for both sexes since 1995, with a total of 312 cases of post-vaccination syncope.)
Now you can merge those figures statistically into the population until they’re not there anymore. Even 2,172 cases are a blip among the millions of doses administered.
Or you can join the airheads who say, “FGS, would you rather your kid had cervical cancer than risk fainting? Mine will get the shot even if they’re laid out on the floor!” Totally ignoring, of course, the fact that it’s not an either/or choice and that a) the risk of cervical cancer is tiny b) Gardasil is only 17-45 percent effective in preventing pre-cancerous cells c) fainting isn’t the only potential side-effect and could be the sign of something else going on.
But I’d have a lot more respect for Merck, the CDC, the FDA, and yes, those bloggers, if they said, hang on. It’s probably nothing, but if over five times as many kids are fainting, shouldn’t we check it out? Is this the canary in the coal mine? Could VLPs, never before used, be having an effect we really know nothing about?
Well, duh.
But right on cue, here come the usually male-generated media and blog comments about how teenage girls faint all over the place anyway. Couldn’t possibly because of this particular vaccine. Here’s a typical comment:
“Now ask yourself: If you line up a bunch of giddy 13-year-old girls for an injection that has something to do with sex, cancer and genital warts, would you expect more or fewer than 2 in 10,000 to faint during the process?” The writer goes on to jokingly (one assumes) wonder whether Gardasil isn’t actually preventing mass fainting.
I don’t think I’ve heard a man wonder out loud whether the mention of sex—faugh, Sir!—wouldn’t make a woman faint since I read a cartload of 19th century novels in college a few decades ago.
Can there really be people out there who are unaware that the average 13-year old (and indeed the average 11 or 12 year old) is not only quite au fait with the oh-so-shivery idea of sex but, sadly, might even be quite practiced in the art of doing various unspeakable things? And that these kids have obligingly held out their arms to get stuck many, many times since infancy, usually without even asking what the damn needle is for?
Trust me, that’s not why they’re fainting. Even Merck is prepared to admit that the genetically-engineered ‘virus-like particles’ (VLPs) in this novel type of vaccine might have something to do with both the fainting and with the more severe and longer-lasting pain associated with Gardasil.
My own 16-year old has an almost pathological fear of needles. My ultimate threat when she breaks curfew is an acupuncture appointment (I know, but it’ll give her lots to talk about when she’s in therapy later). As a six year-old she actually bit the doctor who tried to give her an MMR booster, and last year literally back backed away like a startled horse over a truly fearsome shot being given her in preparation for a trip to India.
But she has never, not once, come even remotely close to fainting.
I’ll grant you that adolescent girls are more likely to be on faint-worthy crash diets than toddlers, so let’s look at the numbers reported to VAERS, the notoriously fallible vaccine adverse event reporting system. We’ll compare them to the numbers for Menactra, since it’s given to roughly the same crash-dieting teenage crowd.
2,172 girls have suffered syncope after being given the Gardasil vaccine. Out of 463 teens who’ve suffered syncope after the Menactra vaccine, 389 were girls and 6 sex unknown.
So roughly five and a half times as many girls have fainted after receiving the Gardasil vaccine as after Menactra, and Menactra has been on offer for about a year and a half longer than Gardasil, which went on sale in 2006, and is routinely given to both boys and girls. (Compare that to the chicken pox vaccine, part of vaccination programs for both sexes since 1995, with a total of 312 cases of post-vaccination syncope.)
Now you can merge those figures statistically into the population until they’re not there anymore. Even 2,172 cases are a blip among the millions of doses administered.
Or you can join the airheads who say, “FGS, would you rather your kid had cervical cancer than risk fainting? Mine will get the shot even if they’re laid out on the floor!” Totally ignoring, of course, the fact that it’s not an either/or choice and that a) the risk of cervical cancer is tiny b) Gardasil is only 17-45 percent effective in preventing pre-cancerous cells c) fainting isn’t the only potential side-effect and could be the sign of something else going on.
But I’d have a lot more respect for Merck, the CDC, the FDA, and yes, those bloggers, if they said, hang on. It’s probably nothing, but if over five times as many kids are fainting, shouldn’t we check it out? Is this the canary in the coal mine? Could VLPs, never before used, be having an effect we really know nothing about?
Monday, June 15, 2009
Gardasil, Oprah, and Crazy Talk
Me, I don’t watch Oprah. Nothing personal—I just don’t watch a whole lot of TV. But I do occasionally read the Oprah magazine, and find it to be exceptionally well written and usually informative. Would I take everything as gospel? Nope. But would I dismiss it out of hand? That’s also a nope.
Newsweek is apparently far better at the dismissing business.
Ambushed by an intriguing cover, featuring a totally deranged-looking Oprah and a story title that read, CRAZY TALK – OPRAH, WACKY CURES AND YOU, who could resist? So I didn’t.
I don’t know a thing about Suzanne Somers. Couldn’t tell you what The Secret is if it bit me. And no doubt Newsweek writers Weston Kosova and Pat Wingert made some excellent points about both (60 supplements a day? Seriously? Does Ms. Somers rattle like a rainstick?)
But I’ve been researching HPV and Gardasil a lot, so my attention was caught by mention of one of Oprah’s ‘regular experts,’ Dr. Christiane Northrup. Again, I don’t know a lot about her, but what I have heard always seemed pretty sensible, so it was rather a shock to find Newsweek putting her in the crazy category when she talked about Gardasil.
“Where I’d put my money,” she’s quoted as saying, “is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?”
You can practically hear the guffaws as the writers note that “…Oprah (did not) question Northrup’s assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood (Susan Wood, former head of the FDA’s Office of Women’s health) says dryly, ‘no evidence that money spent on general health promotion’ will do that.”
Now, I really hope that their general level of research is a lot better than that, because clearly they don’t know what the devil they’re snickering at. And nor does Ms. Wood, unless they truncated her comments.
True, Gardasil aims to protect women against four strains of HPV, the human papillomavirus, which is a virus that is spread through sexual and sometimes not-so-sexual skin-to-skin contact. And persistent infections, caused by any of about 40 strains of HPV out of more than a hundred, can indeed cause cervical cancer.
What these authors don’t seem to have properly researched is that roughly 80 percent of the population will be infected with HPV at some point in their lives, and as many as 95 percent of those infections will be cleared by the body. It’s only when an infection becomes persistent that it causes trouble. And why does an infection fail to clear itself?
Because of a crappy immune system. And why would an immune system be crappy? Often—not always, of course, but often—because of a crappy diet, sorely lacking in fruits and veggies.
A University of Arizona study that was reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be somewhat less protective than vegetables, but still proved to be a valuable addition to creating a strong immune system.
Smoking, incidentally, also damages a body’s natural immunity, increasing the risk of developing pre-cancerous lesions by up to a whopping 27 times, presumably because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. For more info on that, check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
Strengthening the host is usually far more effective than trying to stop a virus, which has a nasty habit of sending in different strains as a replacement disease (think the common cold). Given that the latest studies show Gardasil to be only 17-45 percent effective against pre-cancerous cells, I’d certainly keep chowing down on the broccoli and kohlrabi, myself.
So Northrup is certainly not out in left field when she talks about enhancing the immune system so that one can resist ‘that sort of thing.’ On the contrary, science is on her side.
And when I read an article that is so obviously slanted towards the premise that Oprah is nuts and spreads 'crazy talk', it makes me wonder how accurate Newsweek's previous offering, showing President Mahmoud Ahmadinejad of Iran looking as if he has failed to eat his prunes for far too long (where do they GET these pictures?) is going to be when I get to it.
Newsweek is apparently far better at the dismissing business.
Ambushed by an intriguing cover, featuring a totally deranged-looking Oprah and a story title that read, CRAZY TALK – OPRAH, WACKY CURES AND YOU, who could resist? So I didn’t.
I don’t know a thing about Suzanne Somers. Couldn’t tell you what The Secret is if it bit me. And no doubt Newsweek writers Weston Kosova and Pat Wingert made some excellent points about both (60 supplements a day? Seriously? Does Ms. Somers rattle like a rainstick?)
But I’ve been researching HPV and Gardasil a lot, so my attention was caught by mention of one of Oprah’s ‘regular experts,’ Dr. Christiane Northrup. Again, I don’t know a lot about her, but what I have heard always seemed pretty sensible, so it was rather a shock to find Newsweek putting her in the crazy category when she talked about Gardasil.
“Where I’d put my money,” she’s quoted as saying, “is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?”
You can practically hear the guffaws as the writers note that “…Oprah (did not) question Northrup’s assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood (Susan Wood, former head of the FDA’s Office of Women’s health) says dryly, ‘no evidence that money spent on general health promotion’ will do that.”
Now, I really hope that their general level of research is a lot better than that, because clearly they don’t know what the devil they’re snickering at. And nor does Ms. Wood, unless they truncated her comments.
True, Gardasil aims to protect women against four strains of HPV, the human papillomavirus, which is a virus that is spread through sexual and sometimes not-so-sexual skin-to-skin contact. And persistent infections, caused by any of about 40 strains of HPV out of more than a hundred, can indeed cause cervical cancer.
What these authors don’t seem to have properly researched is that roughly 80 percent of the population will be infected with HPV at some point in their lives, and as many as 95 percent of those infections will be cleared by the body. It’s only when an infection becomes persistent that it causes trouble. And why does an infection fail to clear itself?
Because of a crappy immune system. And why would an immune system be crappy? Often—not always, of course, but often—because of a crappy diet, sorely lacking in fruits and veggies.
A University of Arizona study that was reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be somewhat less protective than vegetables, but still proved to be a valuable addition to creating a strong immune system.
Smoking, incidentally, also damages a body’s natural immunity, increasing the risk of developing pre-cancerous lesions by up to a whopping 27 times, presumably because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. For more info on that, check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
Strengthening the host is usually far more effective than trying to stop a virus, which has a nasty habit of sending in different strains as a replacement disease (think the common cold). Given that the latest studies show Gardasil to be only 17-45 percent effective against pre-cancerous cells, I’d certainly keep chowing down on the broccoli and kohlrabi, myself.
So Northrup is certainly not out in left field when she talks about enhancing the immune system so that one can resist ‘that sort of thing.’ On the contrary, science is on her side.
And when I read an article that is so obviously slanted towards the premise that Oprah is nuts and spreads 'crazy talk', it makes me wonder how accurate Newsweek's previous offering, showing President Mahmoud Ahmadinejad of Iran looking as if he has failed to eat his prunes for far too long (where do they GET these pictures?) is going to be when I get to it.
Sunday, May 17, 2009
Farrah Fawcett's Cancer, HPV and Gardasil
Farrah Fawcett, like Jade Goody, has focused our attention squarely on the tiny, but very real, dangers of HPV. Last night a documentary dealing with the iconic actress’ struggle with anal cancer aired to an audience of an estimated 8.9 million viewers.
In March all eyes were on reality TV star Jade Goody, who died at the appallingly young age of 27 from cervical cancer. Now Fawcett, known for her portrayal of an abused woman in The Burning Bed and for her longtime role in Charlie’s Angels, has highlighted the perils of anal cancer. In 2006 she was diagnosed with the highly curable cancer and initially was thought have beaten it; the disease, however, returned and spread to her liver.
Furious about on ongoing series of detailed leaks about her condition to the National Enquirer, and knowing that they could only come from staff at the UCLA Medical Center, 62 year-old Fawcett set a trap worthy of the French Resistance and spurred new legislation in California to safeguard patient privacy—and she’s continued to tackle her disease with equal energy, even sharing with the public what was originally supposed to be private video footage of her ordeal as a way to spread awareness.
At least those 8.9 million viewers, then, are now to some extent familiar with the disease. Anal cancer is even rarer than cervical cancer. The American Cancer Society estimates that in 2009 there will be 5, 290 new cases diagnosed in the US, mostly in people in their 60s, and about 3,190 of those will be found in women. Because anal cancer can be treated very effectively if found in time, only about 710 of those cases will die.
It’s thought that the human papillomavirus, HPV, is the cause of anal cancer. As with cervical cancer, many—even most—people will be infected with the virus at some point but it clears itself in roughly 95 percent of cases; only when an infection becomes persistent does it cause real trouble. Smoking, sleeping around, and weakening the immune system through poor diet all increase the chances of an infection becoming persistent (smoking alone can increase the chances by up to 26 times), and in the case of anal cancer, having anal sex is certainly a risk factor. Some patients, however, have no risk factors.
Symptoms can include bleeding or itching around the anus, pain in the anal area, a change in bowel habits, a lump in the anal area, swollen lymph nodes in the anal or groin area, and abnormal discharge from the anus.
Problems can usually be detected with a digital exam during a Pap test, colonoscopy, or prostate cancer screening. Anal cytology testing, a relatively new test that’s rather like an anal Pap smear, can also be performed if a patient is high risk for one reason or another. Fawcett’s battle highlights for us yet again the importance of regular screening.
The new Gardasil vaccine (in use since 2006) aims to protect against two of the most commonly cancer-causing strains of HPV, 16 and 18, as well as two that cause genital warts, although a recent study shows that 16 has for some years been losing ground to non-vaccine types. Because there are more than 100 different strains of HPV, and of those more than 40 can cause cancer, replacement diseases may well be an issue if non-vaccine types decide to fill the biological vacancy left by 16 and 18.
Two recent placebo-controlled studies showed that Gardasil decreased the risk of different types of pre-cancerous cells by 17 to 45 percent. It’s not known how long the vaccine will remain effective but a recent study showed strong protection against HPV type 16 alone for 8.5 years.
The vaccine has been associated with a number of side-effects, including Guillain-Barré Syndrome, an unusually rapid form of ALS, paralysis, and convulsions and epilepsy. No causal link has been definitively proved as yet; critics point to a high number of VAERS reports, particularly compared to Menactra, a vaccine that is aimed at a similar population. When three young girls in Spain lost consciousness and convulsed—the two we know most about have been in and out of intensive care ever since—health authorities determined that the vaccine had not caused the convulsions, but could have triggered them.
Germany and Scotland are both considering changing or ending their HPV vaccination programs because of concerns about the efficacy of the program. Many people are looking to other preventatives currently in the development pipeline, such as an ointment made with GML that would also protect against HIV.
Because of the potential side effects and less than complete protection provided by both Cervarix and Gardasil, consumers should research the pros and cons of the vaccines for themselves Regardless of your opinion about Gardasil as an HPV preventative, however, HPV is indeed an issue that we should all be aware of, and one can only be thankful to public figures like Farrah Fawcett who are willing to go very, very public to that end.
Meanwhile, my very heartfelt prayers are with her, and with her family and friends too.
In March all eyes were on reality TV star Jade Goody, who died at the appallingly young age of 27 from cervical cancer. Now Fawcett, known for her portrayal of an abused woman in The Burning Bed and for her longtime role in Charlie’s Angels, has highlighted the perils of anal cancer. In 2006 she was diagnosed with the highly curable cancer and initially was thought have beaten it; the disease, however, returned and spread to her liver.
Furious about on ongoing series of detailed leaks about her condition to the National Enquirer, and knowing that they could only come from staff at the UCLA Medical Center, 62 year-old Fawcett set a trap worthy of the French Resistance and spurred new legislation in California to safeguard patient privacy—and she’s continued to tackle her disease with equal energy, even sharing with the public what was originally supposed to be private video footage of her ordeal as a way to spread awareness.
At least those 8.9 million viewers, then, are now to some extent familiar with the disease. Anal cancer is even rarer than cervical cancer. The American Cancer Society estimates that in 2009 there will be 5, 290 new cases diagnosed in the US, mostly in people in their 60s, and about 3,190 of those will be found in women. Because anal cancer can be treated very effectively if found in time, only about 710 of those cases will die.
It’s thought that the human papillomavirus, HPV, is the cause of anal cancer. As with cervical cancer, many—even most—people will be infected with the virus at some point but it clears itself in roughly 95 percent of cases; only when an infection becomes persistent does it cause real trouble. Smoking, sleeping around, and weakening the immune system through poor diet all increase the chances of an infection becoming persistent (smoking alone can increase the chances by up to 26 times), and in the case of anal cancer, having anal sex is certainly a risk factor. Some patients, however, have no risk factors.
Symptoms can include bleeding or itching around the anus, pain in the anal area, a change in bowel habits, a lump in the anal area, swollen lymph nodes in the anal or groin area, and abnormal discharge from the anus.
Problems can usually be detected with a digital exam during a Pap test, colonoscopy, or prostate cancer screening. Anal cytology testing, a relatively new test that’s rather like an anal Pap smear, can also be performed if a patient is high risk for one reason or another. Fawcett’s battle highlights for us yet again the importance of regular screening.
The new Gardasil vaccine (in use since 2006) aims to protect against two of the most commonly cancer-causing strains of HPV, 16 and 18, as well as two that cause genital warts, although a recent study shows that 16 has for some years been losing ground to non-vaccine types. Because there are more than 100 different strains of HPV, and of those more than 40 can cause cancer, replacement diseases may well be an issue if non-vaccine types decide to fill the biological vacancy left by 16 and 18.
Two recent placebo-controlled studies showed that Gardasil decreased the risk of different types of pre-cancerous cells by 17 to 45 percent. It’s not known how long the vaccine will remain effective but a recent study showed strong protection against HPV type 16 alone for 8.5 years.
The vaccine has been associated with a number of side-effects, including Guillain-Barré Syndrome, an unusually rapid form of ALS, paralysis, and convulsions and epilepsy. No causal link has been definitively proved as yet; critics point to a high number of VAERS reports, particularly compared to Menactra, a vaccine that is aimed at a similar population. When three young girls in Spain lost consciousness and convulsed—the two we know most about have been in and out of intensive care ever since—health authorities determined that the vaccine had not caused the convulsions, but could have triggered them.
Germany and Scotland are both considering changing or ending their HPV vaccination programs because of concerns about the efficacy of the program. Many people are looking to other preventatives currently in the development pipeline, such as an ointment made with GML that would also protect against HIV.
Because of the potential side effects and less than complete protection provided by both Cervarix and Gardasil, consumers should research the pros and cons of the vaccines for themselves Regardless of your opinion about Gardasil as an HPV preventative, however, HPV is indeed an issue that we should all be aware of, and one can only be thankful to public figures like Farrah Fawcett who are willing to go very, very public to that end.
Meanwhile, my very heartfelt prayers are with her, and with her family and friends too.
Monday, May 4, 2009
Gardasil and the Fake Medical Journal Scandal
By Kristin Johns @ http://www.gardasilhpv.com/
Maybe this doesn’t really belong in a blog focusing solely on Gardasil and HPV, but my jaw hit the ground so hard when I read about this little shocker that I just can’t help myself. And it sure sheds a horrifying light on the lengths that Merck, the manufacturer of Gardasil, will go to for the sake of sales.
Turns out that Merck made up an entire fake medical journal for marketing its osteoporosis drug Fosamax.
Talk about a bone-headed (sorry) scam. The Australasian Journal of Bone and Joint Medicine was published by Elsevier, famed for heavyweight scientific journals such as The Lancet, and contained favorable data for Merck products like Vioxx and Fosamax. According to TheScientist.com, the journal so closely mimicked a traditional, peer-reviewed journal that one George Jelinek, an Australian physician and member of the World Association of Medical Editors, testified in court that "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]" (a Merck subsidiary).
The Scientist’s information came from a look at testimony in a lawsuit filed against Merck by a man who believes his heart attack was caused by Vioxx. “The Federal Court has heard that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies…The drug company also allegedly produced an entire journal—called The Australasian Journal of Bone and Joint Medicine—and passed it off as an independent peer review publication,” reported The Australian on April 9.
The journal apparently had no acknowledgement anywhere in its pages that it was funded solely by Merck, and the editorials were basically summaries of the articles with scant references. In happy phrase, Honorary Editorial Board member and rheumatologist Peter Brooks admitted that he had in the past put his name on a few “advertorials.” Advertorials?
Oh, God. What have medicine, science, and indeed publishing, come to?
I want to believe in medicine and science, I really do. I want to be able to go to my doctor and believe what he says and take his advice. I want to believe that when our pediatrician advises me to get my girls that 3-shot series of Gardasil vaccinations, she’s read up fully on it in objective, well-written and peer-reviewed journals that cover properly-conducted trials. I want to believe that Merck genuinely tries to cure diseases, not just to make money hand-over-fist like some cheap Main Street emporium marketing fashion to gullible teenagers.
But good grief, they’re making it increasingly hard.
Luckily I know enough responsible, ethical scientists and doctors to know that the once-honorable traits of all-encompassing curiosity and genuine caring still exist. I’m pretty sure that my doctor wouldn’t dream of adding spurious medical credibility to “advertorials.”
But on my shelf, I have a little green bottle that I dug out of an ancient dump. Once upon a time, according to its raised lettering, it contained “Doctor Kilmer’s Swamp Root Kidney Cure." I’m starting to wonder whether a few of my medicines shouldn’t go up on that shelf right alongside it.
Maybe this doesn’t really belong in a blog focusing solely on Gardasil and HPV, but my jaw hit the ground so hard when I read about this little shocker that I just can’t help myself. And it sure sheds a horrifying light on the lengths that Merck, the manufacturer of Gardasil, will go to for the sake of sales.
Turns out that Merck made up an entire fake medical journal for marketing its osteoporosis drug Fosamax.
Talk about a bone-headed (sorry) scam. The Australasian Journal of Bone and Joint Medicine was published by Elsevier, famed for heavyweight scientific journals such as The Lancet, and contained favorable data for Merck products like Vioxx and Fosamax. According to TheScientist.com, the journal so closely mimicked a traditional, peer-reviewed journal that one George Jelinek, an Australian physician and member of the World Association of Medical Editors, testified in court that "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]" (a Merck subsidiary).
The Scientist’s information came from a look at testimony in a lawsuit filed against Merck by a man who believes his heart attack was caused by Vioxx. “The Federal Court has heard that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies…The drug company also allegedly produced an entire journal—called The Australasian Journal of Bone and Joint Medicine—and passed it off as an independent peer review publication,” reported The Australian on April 9.
The journal apparently had no acknowledgement anywhere in its pages that it was funded solely by Merck, and the editorials were basically summaries of the articles with scant references. In happy phrase, Honorary Editorial Board member and rheumatologist Peter Brooks admitted that he had in the past put his name on a few “advertorials.” Advertorials?
Oh, God. What have medicine, science, and indeed publishing, come to?
I want to believe in medicine and science, I really do. I want to be able to go to my doctor and believe what he says and take his advice. I want to believe that when our pediatrician advises me to get my girls that 3-shot series of Gardasil vaccinations, she’s read up fully on it in objective, well-written and peer-reviewed journals that cover properly-conducted trials. I want to believe that Merck genuinely tries to cure diseases, not just to make money hand-over-fist like some cheap Main Street emporium marketing fashion to gullible teenagers.
But good grief, they’re making it increasingly hard.
Luckily I know enough responsible, ethical scientists and doctors to know that the once-honorable traits of all-encompassing curiosity and genuine caring still exist. I’m pretty sure that my doctor wouldn’t dream of adding spurious medical credibility to “advertorials.”
But on my shelf, I have a little green bottle that I dug out of an ancient dump. Once upon a time, according to its raised lettering, it contained “Doctor Kilmer’s Swamp Root Kidney Cure." I’m starting to wonder whether a few of my medicines shouldn’t go up on that shelf right alongside it.
Thursday, April 30, 2009
Why Potential Gardasil Side Effects Aren't Reported to VAERS
The whole issue of the vast inadequacies of the VAERS (Vaccine Adverse Event Reporting System) has become a bit of a brain worm for me. After all, in general I’m a believer in vaccines, but it’s essential that we know everything about them that we can—and thoroughly investigate every single possible connection with an adverse event or side effect.
Because (to badly paraphrase John Donne) any child’s death or disability diminishes us, and particularly so if we could have prevented it.
The VAERS issue came up because the parents of Jenny Tetlock asked officials to look into the possibility that the extraordinarily rapid-onset paralysis that was killing their daughter could be connected with the Gardasil vaccination she’d recently received. The huge VAERS database turned up no comparables. And yet when the Tetlocks started a personal blog appealing for help they found two very strong comparables, girls who had also just received the vaccine when they develped a similar form of paralysis. Those other two cases, it turns out, had simply never been reported.
Which has led me to wonder how much VAERS actually encourages reporting. (VAERS reports can be filed by anyone, including parents or patients as well as doctors, nurses and pharmacists). So I duly trotted off to our pediatrician’s office and picked up a flyer—you know, the information sheet you’re handed before you get a vaccination, explaining what, why, and who.
Troll down to section 5, which covers risks. It says that the HPV shot does not appear to cause any serious side-effects (fair enough; there have been no definitive connections that I know of) and that although it COULD cause a serious problem such as a severe allergic reaction, the risk of any vaccine causing serious harm or death is very small (again, fair enough, if you’re talking about direct causation. We don’t know a whole lot about the other kind one way or another).
It explains that mild reactions include pain at the site (duh!!), redness or swelling at the site, mild fever, itching, and moderate fever. Fine.
Then I start to get crabby.
“Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.”
Now, that’s reasonable, followed as it is in section 6 by an explanation of the symptoms of severe allergic reaction—high fever, behavior changes, difficulty breathing, wheezing, hoarseness, hives, paleness, weakness, a fast heart beat or dizziness. After advice about what to do, it requests you to ask your doctor to contact VAERS, or do so yourself, if you or your child experience a severe allergic reaction and explains how. Again, fine.
So why am I crabby?
Because the very, very clear implication is that an immediate allergic reaction is the only serious side effect or adverse event that could possibly be connected to Gardasil—or any other vaccine, for that matter. There's not even a mention of Guillain-Barré syndrome, although a recent study found that there appears to be an increased risk of its appearance in the two to six weeks following vaccination with Gardasil.
No wonder the parents of those other paralyzed girls didn’t think to report the paralysis to VAERS. There may be a connection, there may not be. There may be a connection between other adverse events and Gardasil, or there may not be. It may be reasonable to say that if a vaccine can, even rarely, immediately cause your body to react badly, it could also cause a slower adverse reaction in some people. Or it may not be. But the government body that advises parents to get these vaccines for their kids has a duty to investigate fully and to encourage the reporting of ALL potential reactions, not just immediate and severe allergic reaction; and so do the companies that sell the vaccines.
There’s a petition for reform of the VAERS system over at http://www.thepetitionsite.com/1/oneclickonelife, or you can access it via the site http://oneclickonelife.org/.
I don’t care whether you think Gardasil is the devil in disguise or the best thing since Starbucks ice cream: please zip over there and sign it. Regardless of your views on vaccines or experience with them, our kids deserve the best immunizations and the best monitoring systems we can give them.
Because (to badly paraphrase John Donne) any child’s death or disability diminishes us, and particularly so if we could have prevented it.
The VAERS issue came up because the parents of Jenny Tetlock asked officials to look into the possibility that the extraordinarily rapid-onset paralysis that was killing their daughter could be connected with the Gardasil vaccination she’d recently received. The huge VAERS database turned up no comparables. And yet when the Tetlocks started a personal blog appealing for help they found two very strong comparables, girls who had also just received the vaccine when they develped a similar form of paralysis. Those other two cases, it turns out, had simply never been reported.
Which has led me to wonder how much VAERS actually encourages reporting. (VAERS reports can be filed by anyone, including parents or patients as well as doctors, nurses and pharmacists). So I duly trotted off to our pediatrician’s office and picked up a flyer—you know, the information sheet you’re handed before you get a vaccination, explaining what, why, and who.
Troll down to section 5, which covers risks. It says that the HPV shot does not appear to cause any serious side-effects (fair enough; there have been no definitive connections that I know of) and that although it COULD cause a serious problem such as a severe allergic reaction, the risk of any vaccine causing serious harm or death is very small (again, fair enough, if you’re talking about direct causation. We don’t know a whole lot about the other kind one way or another).
It explains that mild reactions include pain at the site (duh!!), redness or swelling at the site, mild fever, itching, and moderate fever. Fine.
Then I start to get crabby.
“Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.”
Now, that’s reasonable, followed as it is in section 6 by an explanation of the symptoms of severe allergic reaction—high fever, behavior changes, difficulty breathing, wheezing, hoarseness, hives, paleness, weakness, a fast heart beat or dizziness. After advice about what to do, it requests you to ask your doctor to contact VAERS, or do so yourself, if you or your child experience a severe allergic reaction and explains how. Again, fine.
So why am I crabby?
Because the very, very clear implication is that an immediate allergic reaction is the only serious side effect or adverse event that could possibly be connected to Gardasil—or any other vaccine, for that matter. There's not even a mention of Guillain-Barré syndrome, although a recent study found that there appears to be an increased risk of its appearance in the two to six weeks following vaccination with Gardasil.
No wonder the parents of those other paralyzed girls didn’t think to report the paralysis to VAERS. There may be a connection, there may not be. There may be a connection between other adverse events and Gardasil, or there may not be. It may be reasonable to say that if a vaccine can, even rarely, immediately cause your body to react badly, it could also cause a slower adverse reaction in some people. Or it may not be. But the government body that advises parents to get these vaccines for their kids has a duty to investigate fully and to encourage the reporting of ALL potential reactions, not just immediate and severe allergic reaction; and so do the companies that sell the vaccines.
There’s a petition for reform of the VAERS system over at http://www.thepetitionsite.com/1/oneclickonelife, or you can access it via the site http://oneclickonelife.org/.
I don’t care whether you think Gardasil is the devil in disguise or the best thing since Starbucks ice cream: please zip over there and sign it. Regardless of your views on vaccines or experience with them, our kids deserve the best immunizations and the best monitoring systems we can give them.
Thursday, April 16, 2009
One Click for Jenny: Gardasil Question Leads to Plea for Overhauling VAERS
So here’s the thing. We can trust in the safety of the HPV vaccine Gardasil—even though it was tested for only a relatively short time before hitting the market—because the government is monitoring it, right?
Sorry. VAERS, a.k.a. the Vaccine Adverse Event Reporting System, is very far from infallible. And one little personal blog, Jenny’s Journey, has proved that by outperforming it.
Jenny Tetlock developed a mysterious paralysis shortly after receiving the Gardasil vaccine. Despite extensive testing no-one could determine whether she was being rapidly killed by ALS or by an autoimmune disease that mimicked ALS. Jenny died last month, less than two years later, at the shatteringly young age of 15.
Jenny’s parents, although cautious about flinging the blame on Gardasil, had asked VAERS to investigate the possibility that Gardasil could have triggered Jenny’s condition. The mighty VAERS system came up with absolutely no comparables, and thus decided that a link was virtually impossible. A neurologist did later independently discover a possible comparable buried in the system; however there was insufficient contact information for verification.
Upstart site Jenny’s Journey, the Tetlock's personal blogsite, came up with two strong comparables. Two strong comparables that had up until then gone unreported to VAERS because the girls’ parents and doctors hadn’t even considered that their unusually rapidly progressing ALS could be connected to their recent Gardasil shots. And sadly, there's a real possibility that if a small and under-publicized site could find those two girls, there could well be even more.
We’re all busy people, so in case you have no time or inclination to read further, I’ll cut to the chase before describing the limits of VAERS: please go to http://oneclickonelife.org/ to sign a petition to get the “dinosaur” VAERS system overhauled. Regardless of whether you’re a Gardasil enthusiast, a no-vaccines-ever parent, or you’re simply concerned about making sure that vaccines “for the public good” are just as good as they can be, please check out the petition. It’s important. We need to fix VAERS.
Why is VAERS So Inadequate?
For one thing, it’s totally voluntary and poorly advertised. Although parents, pharmacists, doctors and patients may all fill out the forms, it is estimated that perhaps ten percent of all side effects and adverse events are actually reported.
First, you’d have to connect the dots, perhaps days or weeks or even months after the event—something that is often difficult, particularly at a stressful time. Then you’d have to know what to do. Although parents are typically given a vaccine information sheet that includes the VAERS website and phone numbers at the time of their child’s shot, most don’t read it, tossing it immediately because they don’t expect a serious reaction. If they do get to the VAERS website, it can be cumbersome and confusing.
“I know the family of a young lady who just died of a debilitating neural disorder, possibly triggered by the Gardasil vaccine. Their attempts to use the Vaccine Adverse Events Reporting System were deeply disappointing,” commented one signer of the petition.
Doctors, already overloaded with paperwork and red tape, don't often tap into the system. Those that do use it report that it ain’t easy. Two comments from the petition:
“Improvement of the VAER is exactly the type of step we should be taking to allow technology to improve patient care, not harm it. I fully support the efforts of OneClickOneLife to harness technology to improve this vastly outdated system. As a practicing physician I have found it tremendously cumbersome to report any adverse effect of any drug therapy which is not only unfortunate but unconscionable given the technology that now exists.”
“I am an employee in the health care field whom has completed the VAERS form. It is not user friendly, complete in all needed documentation and is out dated.”
And something doctors don’t like to discuss: it’s not easy to admit that the vaccine you’ve advocated and administered may be causing problems. Many parents ask pediatricians, “Would you give it to YOUR child?” We’re almost always confidently told “of course!”
Furthermore, doctors, researchers, scientists and even pharmaceutical executives are only human. Dr. John Colquhoun, Auckland’s principal dental officer in the 80s, came to regret strenuously advocating the fluoridation of Auckland’s water while ignoring evidence that dental decay was already rapidly declining. Whether or not you’re a fan of fluoride, his conclusion is interesting.
“I now know that what my colleagues and I were doing is what the history of science shows all professionals do when their pet theory is confronted by disconcerting new evidence: they bend over backwards to explain away the new evidence,” he wrote. “They try very hard to keep their theory intact—especially so if their own professional reputations depend on maintaining that theory.”
Complete and Accurate?
And then there’s accuracy. Perhaps because of the archaic nature of the reporting system, many reports don’t have enough information for follow-up or verification; others are simply erroneous.
Deborah Kotz, who has written several thoughtful and informative articles about Gardasil for US News and World Reports, noted that Chris Tarsell’s sudden death after receiving a Gardasil shot was wrongly reported to VAERS. Her doctor informed VAERS that the autopsy found that Chris had died of “an inflammation of the spleen caused by a life-threatening virus.” Although some minor inflammation of the spleen had been found, the report had in fact concluded that the death was due to "cardiac arrest, cause undetermined."
There’s also jumping-to-conclusions-itis—something that the Tetlocks have tried hard to avoid. Parents hear that there are concerns about Gardasil, say, and immediately assume that any little thing is connected to the shots. While over-reporting is to my mind infinitely preferable to under-reporting, it can overload and confuse the system.
Follow-Up
Several comments on the petition highlight the lack of follow-up. One would think that if one reported a serious adverse effect, the FDA would be on your doorstep shortly; apparently one could well be wrong.
VAERS data should eventually get to the Clinical Immunization Safety Assessment (CISA) Network, a national network of six medical research centers with expertise in immunization safety which research immunization-associated health issues. But those particular mills appear to grind exceeding slow, and unless there is an unmistakable pattern with significant numbers of individuals affected, adverse events will be dismissed as “unlikely connections”. And the Vaccine Safety Data Link, developed in conjunction with several large HMOS, tracks vaccines but doesn’t necessarily connect dots with cases such as Jenny’s.
According to Kotz, the CDC is now finally investigating the three related cases of ALS and has acknowledged that the question of ALS triggered by a vaccine has occurred before, when military personnel were vaccinated against anthrax. CDC officials don’t believe there’s a link, however, but also acknowledged that the media is essential to getting the word out about vaccine issues and encouraging doctors to file reports. Oy vey. While I’m glad that reporters like Kotz are paying attention and following up, shouldn’t a tax dollar or two be spared for that?
Should Wal-Mart take Over VAERS?
Again and again I hear and read complaints about the sheer incompetence of the VAERS system. It’s enough to make me wonder whether Wal-Mart should take it over.
After all, if Wally World’s incredibly creepy information and tracking system is sensitive enough to send Pop-Tarts to soon-to-be hurricane-ravaged towns in an instant, wouldn’t it be infinitely more useful tracking and analyzing information that could save lives? It notoriously did a better job than our government after Hurricane Katrina. And Wally World sure seems to know how to get people’s attention.
OK, I’m Finished Now…
…but again, please go to oneclickonelife.org to sign the petition to bring our creaking VAERS system into the 21st century.
I strongly believe that vaccinations save lives, but I just as strongly believe that there are things about them that we don’t know yet. If VAERS can help to identify small patterns, not just large ones, that can help identify those people who ought not to get vaccinations because of, say, a family history of autoimmune disease, shouldn’t we make sure that it does so?And if your child has been vaccinated with Gardasil, follow through and insist that your doctor does the same by reporting on any side effects or adverse events at:
Vaccine Adverse Event Reporting System (VAERS) – A government program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
RateADrug.com – Quick 5 minute, anonymous Gardasil survey. RateADrug is a community site for sharing experiences and learning about risks and benefits of prescription medications and alternative treatments. Post comments and view other people’s experiences with Gardasil.
National Vaccine Information Center (NVIC) –Long questionnaire. This is a non-profit organization that advocates vaccine safety and preventing vaccine injury through education.
Sorry. VAERS, a.k.a. the Vaccine Adverse Event Reporting System, is very far from infallible. And one little personal blog, Jenny’s Journey, has proved that by outperforming it.
Jenny Tetlock developed a mysterious paralysis shortly after receiving the Gardasil vaccine. Despite extensive testing no-one could determine whether she was being rapidly killed by ALS or by an autoimmune disease that mimicked ALS. Jenny died last month, less than two years later, at the shatteringly young age of 15.
Jenny’s parents, although cautious about flinging the blame on Gardasil, had asked VAERS to investigate the possibility that Gardasil could have triggered Jenny’s condition. The mighty VAERS system came up with absolutely no comparables, and thus decided that a link was virtually impossible. A neurologist did later independently discover a possible comparable buried in the system; however there was insufficient contact information for verification.
Upstart site Jenny’s Journey, the Tetlock's personal blogsite, came up with two strong comparables. Two strong comparables that had up until then gone unreported to VAERS because the girls’ parents and doctors hadn’t even considered that their unusually rapidly progressing ALS could be connected to their recent Gardasil shots. And sadly, there's a real possibility that if a small and under-publicized site could find those two girls, there could well be even more.
We’re all busy people, so in case you have no time or inclination to read further, I’ll cut to the chase before describing the limits of VAERS: please go to http://oneclickonelife.org/ to sign a petition to get the “dinosaur” VAERS system overhauled. Regardless of whether you’re a Gardasil enthusiast, a no-vaccines-ever parent, or you’re simply concerned about making sure that vaccines “for the public good” are just as good as they can be, please check out the petition. It’s important. We need to fix VAERS.
Why is VAERS So Inadequate?
For one thing, it’s totally voluntary and poorly advertised. Although parents, pharmacists, doctors and patients may all fill out the forms, it is estimated that perhaps ten percent of all side effects and adverse events are actually reported.
First, you’d have to connect the dots, perhaps days or weeks or even months after the event—something that is often difficult, particularly at a stressful time. Then you’d have to know what to do. Although parents are typically given a vaccine information sheet that includes the VAERS website and phone numbers at the time of their child’s shot, most don’t read it, tossing it immediately because they don’t expect a serious reaction. If they do get to the VAERS website, it can be cumbersome and confusing.
“I know the family of a young lady who just died of a debilitating neural disorder, possibly triggered by the Gardasil vaccine. Their attempts to use the Vaccine Adverse Events Reporting System were deeply disappointing,” commented one signer of the petition.
Doctors, already overloaded with paperwork and red tape, don't often tap into the system. Those that do use it report that it ain’t easy. Two comments from the petition:
“Improvement of the VAER is exactly the type of step we should be taking to allow technology to improve patient care, not harm it. I fully support the efforts of OneClickOneLife to harness technology to improve this vastly outdated system. As a practicing physician I have found it tremendously cumbersome to report any adverse effect of any drug therapy which is not only unfortunate but unconscionable given the technology that now exists.”
“I am an employee in the health care field whom has completed the VAERS form. It is not user friendly, complete in all needed documentation and is out dated.”
And something doctors don’t like to discuss: it’s not easy to admit that the vaccine you’ve advocated and administered may be causing problems. Many parents ask pediatricians, “Would you give it to YOUR child?” We’re almost always confidently told “of course!”
Furthermore, doctors, researchers, scientists and even pharmaceutical executives are only human. Dr. John Colquhoun, Auckland’s principal dental officer in the 80s, came to regret strenuously advocating the fluoridation of Auckland’s water while ignoring evidence that dental decay was already rapidly declining. Whether or not you’re a fan of fluoride, his conclusion is interesting.
“I now know that what my colleagues and I were doing is what the history of science shows all professionals do when their pet theory is confronted by disconcerting new evidence: they bend over backwards to explain away the new evidence,” he wrote. “They try very hard to keep their theory intact—especially so if their own professional reputations depend on maintaining that theory.”
Complete and Accurate?
And then there’s accuracy. Perhaps because of the archaic nature of the reporting system, many reports don’t have enough information for follow-up or verification; others are simply erroneous.
Deborah Kotz, who has written several thoughtful and informative articles about Gardasil for US News and World Reports, noted that Chris Tarsell’s sudden death after receiving a Gardasil shot was wrongly reported to VAERS. Her doctor informed VAERS that the autopsy found that Chris had died of “an inflammation of the spleen caused by a life-threatening virus.” Although some minor inflammation of the spleen had been found, the report had in fact concluded that the death was due to "cardiac arrest, cause undetermined."
There’s also jumping-to-conclusions-itis—something that the Tetlocks have tried hard to avoid. Parents hear that there are concerns about Gardasil, say, and immediately assume that any little thing is connected to the shots. While over-reporting is to my mind infinitely preferable to under-reporting, it can overload and confuse the system.
Follow-Up
Several comments on the petition highlight the lack of follow-up. One would think that if one reported a serious adverse effect, the FDA would be on your doorstep shortly; apparently one could well be wrong.
VAERS data should eventually get to the Clinical Immunization Safety Assessment (CISA) Network, a national network of six medical research centers with expertise in immunization safety which research immunization-associated health issues. But those particular mills appear to grind exceeding slow, and unless there is an unmistakable pattern with significant numbers of individuals affected, adverse events will be dismissed as “unlikely connections”. And the Vaccine Safety Data Link, developed in conjunction with several large HMOS, tracks vaccines but doesn’t necessarily connect dots with cases such as Jenny’s.
According to Kotz, the CDC is now finally investigating the three related cases of ALS and has acknowledged that the question of ALS triggered by a vaccine has occurred before, when military personnel were vaccinated against anthrax. CDC officials don’t believe there’s a link, however, but also acknowledged that the media is essential to getting the word out about vaccine issues and encouraging doctors to file reports. Oy vey. While I’m glad that reporters like Kotz are paying attention and following up, shouldn’t a tax dollar or two be spared for that?
Should Wal-Mart take Over VAERS?
Again and again I hear and read complaints about the sheer incompetence of the VAERS system. It’s enough to make me wonder whether Wal-Mart should take it over.
After all, if Wally World’s incredibly creepy information and tracking system is sensitive enough to send Pop-Tarts to soon-to-be hurricane-ravaged towns in an instant, wouldn’t it be infinitely more useful tracking and analyzing information that could save lives? It notoriously did a better job than our government after Hurricane Katrina. And Wally World sure seems to know how to get people’s attention.
OK, I’m Finished Now…
…but again, please go to oneclickonelife.org to sign the petition to bring our creaking VAERS system into the 21st century.
I strongly believe that vaccinations save lives, but I just as strongly believe that there are things about them that we don’t know yet. If VAERS can help to identify small patterns, not just large ones, that can help identify those people who ought not to get vaccinations because of, say, a family history of autoimmune disease, shouldn’t we make sure that it does so?And if your child has been vaccinated with Gardasil, follow through and insist that your doctor does the same by reporting on any side effects or adverse events at:
Vaccine Adverse Event Reporting System (VAERS) – A government program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
RateADrug.com – Quick 5 minute, anonymous Gardasil survey. RateADrug is a community site for sharing experiences and learning about risks and benefits of prescription medications and alternative treatments. Post comments and view other people’s experiences with Gardasil.
National Vaccine Information Center (NVIC) –Long questionnaire. This is a non-profit organization that advocates vaccine safety and preventing vaccine injury through education.
Monday, March 23, 2009
Why Gardasil Was Created: Jade Goody Dies of Cervical Cancer
Gardasil is such a controversial and flawed vaccine that it seems as if many people can think of it only as a much-hyped profit center for Merck.
But 27 year-old British celebrity Jade Goody’s death of cervical cancer on Sunday, Mother’s Day in Britain, reminds us that yeah, cervical cancer can kill. If an HPV infection is NOT shrugged off, as most are, and you don’t get an annual Pap smear to find pre-cancerous lesions early, then it can eventually kill. And we should take it seriously.
Which is why researchers probably saw the Gardasil vaccine as the Grail—regardless of what Merck did with it afterwards, by fast-tracking it to approval and marketing it aggressively; whatever your feelings about Gardasil, we have to give researchers credit.
Jade Goody was a dental assistant when she soared to fame on the reality TV show Big Brother which endlessly films contestants corralled in a house for weeks at a time. Born to drug-addicted and impoverished parents she was brash, ignorant, and opinionated, soon becoming notorious for malapropisms such as "They were trying to use me as an escape goat."
But her survivor nature won her many fans, and perversely, she soon became a celebrity just for being a celebrity. There was one hell of a row when she put a racist slant on bullying during the filming of a follow-up Celebrity Big Brother, calling Bollywood actress Shilpa Shetty “Shilpa Poppadum” and snickering at her accent. Mixed race herself, though, she not unreasonably explained that “I treat everyone like that.” The two made it up, and in fact Goody learned about her cancer on camera during the filming of an Indian Big Brother.
Her disease progressed in the glare of camera flashes. She was criticized roundly for selling her life, including the rights to film her fantasy wedding to fiancé Jack Tweed while she was dying: she answered that she was storing up as much money as possible for her two young sons so that they would never live as she did as a child.
Goody did a great deal in Britain to highlight the need for regular exams. Although cervical cancer is not prevalent—in the US it ranks 14th on the list of cancers—and it rarely presents itself in young women, serious lesions resulting from persistent HPV infection do appear to be increasing. In Britain the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.
Gardasil has its issues, and I won’t be getting it for my daughters. But at least Merck’s scare tactics have raised awareness of HPV and the need for precautions, and I thank them for leading me to look at the alternatives (February 9, March 10).
Hopefully my girls will be sufficiently aware of HPV that they will never suffer as Jade Goody has. My thoughts and prayers go with her.
But 27 year-old British celebrity Jade Goody’s death of cervical cancer on Sunday, Mother’s Day in Britain, reminds us that yeah, cervical cancer can kill. If an HPV infection is NOT shrugged off, as most are, and you don’t get an annual Pap smear to find pre-cancerous lesions early, then it can eventually kill. And we should take it seriously.
Which is why researchers probably saw the Gardasil vaccine as the Grail—regardless of what Merck did with it afterwards, by fast-tracking it to approval and marketing it aggressively; whatever your feelings about Gardasil, we have to give researchers credit.
Jade Goody was a dental assistant when she soared to fame on the reality TV show Big Brother which endlessly films contestants corralled in a house for weeks at a time. Born to drug-addicted and impoverished parents she was brash, ignorant, and opinionated, soon becoming notorious for malapropisms such as "They were trying to use me as an escape goat."
But her survivor nature won her many fans, and perversely, she soon became a celebrity just for being a celebrity. There was one hell of a row when she put a racist slant on bullying during the filming of a follow-up Celebrity Big Brother, calling Bollywood actress Shilpa Shetty “Shilpa Poppadum” and snickering at her accent. Mixed race herself, though, she not unreasonably explained that “I treat everyone like that.” The two made it up, and in fact Goody learned about her cancer on camera during the filming of an Indian Big Brother.
Her disease progressed in the glare of camera flashes. She was criticized roundly for selling her life, including the rights to film her fantasy wedding to fiancé Jack Tweed while she was dying: she answered that she was storing up as much money as possible for her two young sons so that they would never live as she did as a child.
Goody did a great deal in Britain to highlight the need for regular exams. Although cervical cancer is not prevalent—in the US it ranks 14th on the list of cancers—and it rarely presents itself in young women, serious lesions resulting from persistent HPV infection do appear to be increasing. In Britain the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.
Gardasil has its issues, and I won’t be getting it for my daughters. But at least Merck’s scare tactics have raised awareness of HPV and the need for precautions, and I thank them for leading me to look at the alternatives (February 9, March 10).
Hopefully my girls will be sufficiently aware of HPV that they will never suffer as Jade Goody has. My thoughts and prayers go with her.
Wednesday, March 18, 2009
Jenny’s Journey Ends: Gardasil Questions Remain
It’s impossible not to cry, reading that Jenny Tetlock, the impish 15-year old whose struggle with a mystery ALS-like disease is chronicled on the blog Jenny’s Journey, died on March 15th.
I first stumbled on the blog right after I’d hauled a carload of laughing, slightly obsessed young girls to their second viewing of the movie Twilight. To read that Jenny had had to make two attempts to see the movie just once broke my heart, and like so many other people, I returned to the blog again and again, hoping that someone smart, somewhere in the world, would crack her case.
Jenny’s struggle was especially moving not because of her parents’ private agony, but because of their measured public response. They made it very clear that they did not want Jenny to become “the poster child” for an anti-Gardasil outcry. What they wanted was for doctors and researchers to find the cause and cure, whatever it might prove to be, for Jenny’s devastating illness. But they also wanted them to take a possible connection with the HPV vaccine Gardasil seriously.
Jenny’s symptoms became apparent shortly after her third Gardasil shot when she was suddenly unable to clear a hurdle that the other kids in her class could clear easily. With startling rapidity she became a quadriplegic, unable to breathe on her own for more than a second or two.
“Despite over a year of intensive testing at several of the country’s top medical centers, doctors still aren’t sure what has caused Jenny’s paralysis,” reads a post on Jenny’s Journey. “Some (mostly neurologists) believe that she has an unusual, rapidly progressive form of juvenile ALS – the same disease that confines Stephen Hawking to a wheelchair. Others (mostly immunologists) think she may have a rare autoimmune disease that mimics ALS…her family hesitates to declare Gardasil the cause of her illness without scientific evidence, but some MDs at top hospitals see the connection as possible and even plausible.”
They appealed for people with similar issues, with or without the Gardasil HPV connection, to contact them. One such was Whitney Baird, who died last August at the age of 22, just 13 months after being vaccinated with Gardasil. Like Jenny she had had an autoimmune skin disorder and developmental delays as a child, and her condition also deteriorated extraordinarily rapidly, raising the possibility that Gardasil had triggered a reaction that had started killing off motor neurons.
Autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger,” according to the Lancet, and my posts about the autoimmune disease/ Gardasil connection (February 2 and 4) included this:
“As examples, Dr. Harper (Dr. Diane Harper, who was involved in Gardasil’s clinical trials) mentioned family history of motor neuron disease or autoimmune diseases, which could affect how the person reacts to the vaccine,” wrote medical journalist Zosia Chustecka. “She illustrated this point by saying: ‘Salt does not usually kill anybody, but for a person with congestive heart failure, it could lead to fatal pulmonary edema, so you could say that salt caused their death, as it was the last straw that broke the camel's back.’
There’s also the aluminum connection. A high incidence of ALS in the Western Pacific was linked to dietary toxins such as aluminum; research into a spike of possibly heavy metal-related ALS cases in Gulf War veterans is ongoing.
Jenny’s family notes that since going public with Jenny’s illness, they have found two other cases of ALS following vaccination with Gardasil (the families had not previously thought to report them to VAERS) and learned of two more possible cases. Five cases make two beyond the norm for this age group, and the VAERS system is notoriously fallible and under-used.
Jenny’s parents, quite rightly, don’t want to just throw her disease randomly on the HPV vaccine's doorstep. There may not be a connection at all, although there are certainly very reasonable grounds for suspicion and their questions deserve to be investigated.
Science can be loosely defined as “what we know so far.” The Tetlocks just want us to advance that knowledge a little.
Meanwhile, my heart goes out to Jenny’s family; losing a beloved child is utterly unimaginable. Thank you for your persistence and thank you for making us ask questions. I hope that you will find some measure of peace once we have answers.
And Godspeed, Jenny.
I first stumbled on the blog right after I’d hauled a carload of laughing, slightly obsessed young girls to their second viewing of the movie Twilight. To read that Jenny had had to make two attempts to see the movie just once broke my heart, and like so many other people, I returned to the blog again and again, hoping that someone smart, somewhere in the world, would crack her case.
Jenny’s struggle was especially moving not because of her parents’ private agony, but because of their measured public response. They made it very clear that they did not want Jenny to become “the poster child” for an anti-Gardasil outcry. What they wanted was for doctors and researchers to find the cause and cure, whatever it might prove to be, for Jenny’s devastating illness. But they also wanted them to take a possible connection with the HPV vaccine Gardasil seriously.
Jenny’s symptoms became apparent shortly after her third Gardasil shot when she was suddenly unable to clear a hurdle that the other kids in her class could clear easily. With startling rapidity she became a quadriplegic, unable to breathe on her own for more than a second or two.
“Despite over a year of intensive testing at several of the country’s top medical centers, doctors still aren’t sure what has caused Jenny’s paralysis,” reads a post on Jenny’s Journey. “Some (mostly neurologists) believe that she has an unusual, rapidly progressive form of juvenile ALS – the same disease that confines Stephen Hawking to a wheelchair. Others (mostly immunologists) think she may have a rare autoimmune disease that mimics ALS…her family hesitates to declare Gardasil the cause of her illness without scientific evidence, but some MDs at top hospitals see the connection as possible and even plausible.”
They appealed for people with similar issues, with or without the Gardasil HPV connection, to contact them. One such was Whitney Baird, who died last August at the age of 22, just 13 months after being vaccinated with Gardasil. Like Jenny she had had an autoimmune skin disorder and developmental delays as a child, and her condition also deteriorated extraordinarily rapidly, raising the possibility that Gardasil had triggered a reaction that had started killing off motor neurons.
Autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger,” according to the Lancet, and my posts about the autoimmune disease/ Gardasil connection (February 2 and 4) included this:
“As examples, Dr. Harper (Dr. Diane Harper, who was involved in Gardasil’s clinical trials) mentioned family history of motor neuron disease or autoimmune diseases, which could affect how the person reacts to the vaccine,” wrote medical journalist Zosia Chustecka. “She illustrated this point by saying: ‘Salt does not usually kill anybody, but for a person with congestive heart failure, it could lead to fatal pulmonary edema, so you could say that salt caused their death, as it was the last straw that broke the camel's back.’
There’s also the aluminum connection. A high incidence of ALS in the Western Pacific was linked to dietary toxins such as aluminum; research into a spike of possibly heavy metal-related ALS cases in Gulf War veterans is ongoing.
Jenny’s family notes that since going public with Jenny’s illness, they have found two other cases of ALS following vaccination with Gardasil (the families had not previously thought to report them to VAERS) and learned of two more possible cases. Five cases make two beyond the norm for this age group, and the VAERS system is notoriously fallible and under-used.
Jenny’s parents, quite rightly, don’t want to just throw her disease randomly on the HPV vaccine's doorstep. There may not be a connection at all, although there are certainly very reasonable grounds for suspicion and their questions deserve to be investigated.
Science can be loosely defined as “what we know so far.” The Tetlocks just want us to advance that knowledge a little.
Meanwhile, my heart goes out to Jenny’s family; losing a beloved child is utterly unimaginable. Thank you for your persistence and thank you for making us ask questions. I hope that you will find some measure of peace once we have answers.
And Godspeed, Jenny.
Tuesday, March 10, 2009
Will Carrageenan or GML Prove More Effective in Preventing HPV Than Gardasil?
Could either (or both) of two commonly-used natural compounds—compounds that most people already consume frequently and safely—work better for preventing HPV infections than the Gardasil vaccination?
The short answer is that scientists don’t quite know yet, but things look extremely promising.
The Gardasil vaccine protects the body from the two strains of HPV (human papilloma virus) that currently cause approximately 70 percent of cervical cancer and the two that cause genital warts. That leaves more than 100 strains of HPV merrily making whoopee. Yikes!
And although many suspected side effects of the Gardasil vaccine, including autoimmune disorders, have been reported, one of the scariest things about it is the potential for replacement diseases. These can develop when unaffected strains of any pathogen rush to fill the void, and it’s exactly what happened with Prevnar. The pneumococcal vaccine had to be reformulated, and will doubtless have to be reformulated again and again as strains like drug-resistant 16A “unexpectedly” become even stronger.
In the case of Gardasil, because many people have lifelong exposure to HPV, multiple booster or reformulated shots seem likely—not such a good thing for the girls whose reaction to Gardasil increases with each of the three shots. Clearly anything that would reliably block ALL strains of HPV would be a vast improvement.
GML
Glycerol monolaurate (GML) recently made headlines when researchers at the University of Minnesota discovered that a vaginally-applied gel containing the naturally occurring compound protected monkeys from becoming infected with HIV.
GML is already widely used as an antimicrobial and anti-inflammatory agent in food and cosmetics, and it is extremely cheap. If the discovery pans out, cheers will be heard around the world. It would have the potential to save millions of lives.
And the compound would very likely protect against other sexually transmitted infections, too—including all strains of the dread HPV. It has already been shown, at least in vitro, to inhibit growth of nearly all sexually transmitted diseases as well as other causes of vaginal infections, yet it doesn’t affect normal bacteria. Because it is so cheap and could probably be sold over-the-counter, it could rapidly become very widely used.
Research is continuing.
Carrageenan
Scientists have been zeroing in on carageenan for a while. Although it’s derived from red seaweed, even the most anti-health food zealot has probably consumed it many times as a thickener in their ice cream, beer or toothpaste
Drs. Douglas Lowy and John Schiller, senior research scientists at NIH's National Cancer Institute, are currently not only working on an HPV shot to be used in developing countries (where the benefits almost certainly outweigh the risks) but also on formulating a preventative ointment, on the principle that since shots are expensive both to buy and to administer, they should look for a simpler approach.
In July 2007 the scientists reported that they had found that a lubricant containing carrageenan was able to very successfully block HPV infection in mice. They’re now organizing a clinical trial to find out whether it will work as effectively in humans.
Interestingly, their study also threw up the possibility that over-the-counter vaginal contraceptives containing the spermicide nonoxynol-9 (N-9) could actually substantially raise the risk for genital HPV infection in women.
A note of caution: As a food additive, carrageenan is suspected of playing a role in intestinal inflammation and possibly inflammatory bowel disease. Also, South African trials of Carraguard, a microbicide containing carrageenan, found it could be safely applied on a daily basis but was ineffective against HIV.
Bottom line: Some personal lubricants already contain carrageenan, so although it would be unwise to rely on them as an HPV preventative at this point, using one liberally (remembering that HPV is spread skin-to-skin) is probably not going to do you any harm and could well have a protective effect. Choose carefully to avoid potential clashes with spermicides etc.
The short answer is that scientists don’t quite know yet, but things look extremely promising.
The Gardasil vaccine protects the body from the two strains of HPV (human papilloma virus) that currently cause approximately 70 percent of cervical cancer and the two that cause genital warts. That leaves more than 100 strains of HPV merrily making whoopee. Yikes!
And although many suspected side effects of the Gardasil vaccine, including autoimmune disorders, have been reported, one of the scariest things about it is the potential for replacement diseases. These can develop when unaffected strains of any pathogen rush to fill the void, and it’s exactly what happened with Prevnar. The pneumococcal vaccine had to be reformulated, and will doubtless have to be reformulated again and again as strains like drug-resistant 16A “unexpectedly” become even stronger.
In the case of Gardasil, because many people have lifelong exposure to HPV, multiple booster or reformulated shots seem likely—not such a good thing for the girls whose reaction to Gardasil increases with each of the three shots. Clearly anything that would reliably block ALL strains of HPV would be a vast improvement.
GML
Glycerol monolaurate (GML) recently made headlines when researchers at the University of Minnesota discovered that a vaginally-applied gel containing the naturally occurring compound protected monkeys from becoming infected with HIV.
GML is already widely used as an antimicrobial and anti-inflammatory agent in food and cosmetics, and it is extremely cheap. If the discovery pans out, cheers will be heard around the world. It would have the potential to save millions of lives.
And the compound would very likely protect against other sexually transmitted infections, too—including all strains of the dread HPV. It has already been shown, at least in vitro, to inhibit growth of nearly all sexually transmitted diseases as well as other causes of vaginal infections, yet it doesn’t affect normal bacteria. Because it is so cheap and could probably be sold over-the-counter, it could rapidly become very widely used.
Research is continuing.
Carrageenan
Scientists have been zeroing in on carageenan for a while. Although it’s derived from red seaweed, even the most anti-health food zealot has probably consumed it many times as a thickener in their ice cream, beer or toothpaste
Drs. Douglas Lowy and John Schiller, senior research scientists at NIH's National Cancer Institute, are currently not only working on an HPV shot to be used in developing countries (where the benefits almost certainly outweigh the risks) but also on formulating a preventative ointment, on the principle that since shots are expensive both to buy and to administer, they should look for a simpler approach.
In July 2007 the scientists reported that they had found that a lubricant containing carrageenan was able to very successfully block HPV infection in mice. They’re now organizing a clinical trial to find out whether it will work as effectively in humans.
Interestingly, their study also threw up the possibility that over-the-counter vaginal contraceptives containing the spermicide nonoxynol-9 (N-9) could actually substantially raise the risk for genital HPV infection in women.
A note of caution: As a food additive, carrageenan is suspected of playing a role in intestinal inflammation and possibly inflammatory bowel disease. Also, South African trials of Carraguard, a microbicide containing carrageenan, found it could be safely applied on a daily basis but was ineffective against HIV.
Bottom line: Some personal lubricants already contain carrageenan, so although it would be unwise to rely on them as an HPV preventative at this point, using one liberally (remembering that HPV is spread skin-to-skin) is probably not going to do you any harm and could well have a protective effect. Choose carefully to avoid potential clashes with spermicides etc.
Friday, February 27, 2009
Dear Blue Cross: Here’s Where to Send Our Gardasil Shots
An Open Letter to Our Health Insurance Company
Dear BlueCross/BlueShield,
Thank you so much for informing me that you would be happy to pay for the three Gardasil shots, and, I assume, booster shots as necessary, for each of my two daughters.
Imagine my joy at hearing this! Particularly, I might add, since over the last 10 years you have declined to pay for a cast for Daughter #1’s broken wrist, a splint for Daughter #2’s sprained ankle, and for most of the cost of an MRI after a head trauma. I am fortunate indeed that the $14,000 I pay you each year to insure our small and mostly healthy family means that you can now afford to pay up for Gardasil.
But here’s the thing. We’ve looked, endlessly, at the risk/reward ratio. In the US, 11,070 women will be diagnosed with cancer this year and 3,870 will die. According to the National Cancer Institute, that makes it the 14th most common cancer for women—pretty far down the list. And attention to lifestyle and regular Pap screenings can dramatically reduce even this small risk.
When Kaiser Permanente studied its members’ records, they found that more than half of the women who had been diagnosed with cervical cancer had not chosen to take advantage of their Pap smear test coverage. That’s not us. We look after ourselves, we eat our veggies, we don’t smoke and we get regular check-ups. And I appreciate Merck’s drawing our attention, albeit rather dramatically, to HPV, but with care the rewards gained by this vaccine appear to be minimal.
On the risk side, I see multiple reports of auto-immune disease and many other side-effects that may or may not be connected to Gardasil. I see evidence that side-effects in susceptible women apparently increase with each of the three shots, and I see that no-one knows if fourth, fifth, and even sixteenth booster shots, or reformulated shots, will be necessary over my daughters’ lifetime. I look at Prevnar, and think about the risks of perhaps even more vicious replacement diseases gaining ground when a shot vanquishes only a few strains of HPV out of more than 100.
So I’m going to decline your kind offer. But wait! You’re not off the hook yet.
Cervical cancer, though not a huge issue in the US, even with some 40 percent of women unable or unwilling to have regular Pap tests, is indeed a big issue in developing countries. In these countries it is the leading cause of cancer-related deaths among women, accounting for 85 percent of the 253,500 annual deaths from cervical cancer worldwide. Clearly the risk/reward ratio is turned on its head in developing nations.
So here’s what I propose. Just send our doses of Gardasil to one of those countries. Africa would be good; I’ve been there and I’m fond of it; but honestly, you can send it wherever the need is greatest. Maybe other Blue Cross/Blue Shield members, or Kaiser Permanente members, or JoeBlow down the street members—in fact anyone who chooses not to get the shots despite coverage—would like to ask their insurance companies to do the same.
How about it, ladies?
Wednesday, February 25, 2009
The Outrageous Jade Goody: Food for Thought about Gardasil and Cervical Cancer
Jade Goody, Britain’s brash reality TV celebrity, is still sparking controversy and discussion even while she’s dying.
Goody’s personal tragedy has done more to highlight the importance of regular smear tests and the risks of casual sex and smoking than perhaps anything else in the UK. When she found out—very publicly—that at the young age of 27 she is unlikely to survive the cervical cancer that has metastasized to her bowel, liver and groin, the rate of women seeking Pap smears in Britain soared by 21 percent.
So what’s to think about? Well…
Is HPV Getting Worse?
International focus on Jade Goody’s case threw up some unpleasant statistics.
Smear tests detect pre-cancerous changes, called CINS, as well as actual cancer. CINS are caused by persistent cases of HPV (human papillomavirus), a very common STD that normally resolves itself. However, in Britain the incidence of cases of the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.
This seems to suggest that any or all of the following are true:
· HPV incidence and virulence is worsening.
· Young women’s immune systems—healthy immune systems are the reason that most HPV cases clear up on their own—are weakening. Britain’s diet has notoriously deteriorated in the past decade, while the prevalence of smoking in the UK is greater in the 20-24 year old age group than in any other, and girls are now more likely to smoke than boys. Smoking increases the chance of an HPV infection becoming persistent by up to 27 times.
· Girls are having more unprotected sex with more partners at a much earlier age.
Bottom line: Regardless of whether you think Gardasil’s a good thing or not, take HPV seriously. Consider that it may be worsening (one of the fears about Gardasil is that it may create fiercer replacement diseases) and take the necessary steps to protect yourself.
Screening Age Row
And then there’s the NHS row. According to the Journal of Family Planning and Reproductive Health Care, researchers are upset with the 2004 NHS (Britain’s National Health Service) decision to quit offering Pap smears to women younger than 25 in England (women in the rest of Britain can still have the test at 20).
The NHS says that it is following guidelines set by the International Agency for Research on Cancer because cervical cancer in under-25s is extremely rare, but changes in the cervix are very common. Screening at 20 could therefore result in unnecessary, frightening, and potentially harmful interventions.
But Professor John Shepherd, a cervical cancer specialist and spokesman for the Royal College of Obstetricians and Gynaecologists, notes that some ten percent of cases are found in women under 30, and believes that younger women should be screened. Experts also note that fewer women come for the test when they start later, perhaps because it has not become a regular part of their adult life; they’re also concerned that women who have had the Cervarix vaccination will think they are fully protected and ignore the necessity for smear tests. Would Jade Goody be looking at a happier outcome had she gone for a Pap smear at 20 or even 25?
Bottom line: The American Cancer Society currently recommends starting regular screenings by three years after becoming sexually active, or by the age of 21, whichever comes first. Do it, whether or not you’ve had the Gardasil shot. Or, if the NHS/IGR guidelines make sense to you, discuss them with your doctor and, at the very outside, get the test by age 25.
Goody’s personal tragedy has done more to highlight the importance of regular smear tests and the risks of casual sex and smoking than perhaps anything else in the UK. When she found out—very publicly—that at the young age of 27 she is unlikely to survive the cervical cancer that has metastasized to her bowel, liver and groin, the rate of women seeking Pap smears in Britain soared by 21 percent.
So what’s to think about? Well…
Is HPV Getting Worse?
International focus on Jade Goody’s case threw up some unpleasant statistics.
Smear tests detect pre-cancerous changes, called CINS, as well as actual cancer. CINS are caused by persistent cases of HPV (human papillomavirus), a very common STD that normally resolves itself. However, in Britain the incidence of cases of the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.
This seems to suggest that any or all of the following are true:
· HPV incidence and virulence is worsening.
· Young women’s immune systems—healthy immune systems are the reason that most HPV cases clear up on their own—are weakening. Britain’s diet has notoriously deteriorated in the past decade, while the prevalence of smoking in the UK is greater in the 20-24 year old age group than in any other, and girls are now more likely to smoke than boys. Smoking increases the chance of an HPV infection becoming persistent by up to 27 times.
· Girls are having more unprotected sex with more partners at a much earlier age.
Bottom line: Regardless of whether you think Gardasil’s a good thing or not, take HPV seriously. Consider that it may be worsening (one of the fears about Gardasil is that it may create fiercer replacement diseases) and take the necessary steps to protect yourself.
Screening Age Row
And then there’s the NHS row. According to the Journal of Family Planning and Reproductive Health Care, researchers are upset with the 2004 NHS (Britain’s National Health Service) decision to quit offering Pap smears to women younger than 25 in England (women in the rest of Britain can still have the test at 20).
The NHS says that it is following guidelines set by the International Agency for Research on Cancer because cervical cancer in under-25s is extremely rare, but changes in the cervix are very common. Screening at 20 could therefore result in unnecessary, frightening, and potentially harmful interventions.
But Professor John Shepherd, a cervical cancer specialist and spokesman for the Royal College of Obstetricians and Gynaecologists, notes that some ten percent of cases are found in women under 30, and believes that younger women should be screened. Experts also note that fewer women come for the test when they start later, perhaps because it has not become a regular part of their adult life; they’re also concerned that women who have had the Cervarix vaccination will think they are fully protected and ignore the necessity for smear tests. Would Jade Goody be looking at a happier outcome had she gone for a Pap smear at 20 or even 25?
Bottom line: The American Cancer Society currently recommends starting regular screenings by three years after becoming sexually active, or by the age of 21, whichever comes first. Do it, whether or not you’ve had the Gardasil shot. Or, if the NHS/IGR guidelines make sense to you, discuss them with your doctor and, at the very outside, get the test by age 25.
Monday, February 9, 2009
Alternatives to the Gardasil Vaccine—Look, No Side Effects
No, I don’t have a snake oil cure for either HPV or cervical cancer.
But while I struggle with the decision about whether or not to vaccinate my daughters with Gardasil, I’m also trying to figure out an alternative strategy. After all, I don’t much like what I’m hearing about Gardasil, but I also have two people in my life who’ve fallen foul of HPV and have each endured two operations.
Gardasil, like it or loathe it, has focused our attention on the high incidence of HPV, and that’s not a bad thing. If you have some ideas about ways to decrease the risk of pre-cancerous or cancerous lesions forming, please chime in down in the comments section. All of us, not just young girls, need to be aware of ways to protect ourselves.
Just get the check-up, already.
Cervical cancer rates plummeted in the US after women began getting regular check-ups, including Pap smears.
The American Cancer Society currently recommends getting regular screenings by three years after becoming sexually active, or by the age of 21, whichever comes first. (Go to caonline.amcancersoc.org/cgi/content/full/52/6/342 for the full guidelines.) Young women should get smears every one to two years, depending on the test used; women over 30 may be able to switch to every three years.
But although it catches 70- 80 percent of lesions, the Pap smear isn’t infallible. Ask whether you should get an HPV test. And ask in particular about the HPV-DNA test. According to the Journal of the National Cancer Institute, doctors can find about 30 percent more cervical cancer cases when women get a HPV-DNA test before their annual Pap test and then, if they test positive, get another test a year later.
Bottom line: cervical cancer is almost always slow-growing. If you’re one of the unlucky ten percent whose HPV infection turns ugly, you have an extremely good chance of fixing it before cervical cancer develops—as long as you get regular screenings.
Focus on strengthening the host rather than killing the invader.
In other words, pay attention to your general health and immune system. At least 90 percent of all HPV infections clear up by themselves, so be one of the people that simply shrug off infection.
· Eat your carrots. Grandma was right, dammit; an apple (plus some leafy greens, citrus, grapes, tomatoes, broccoli, whatever adds up to 5-10 servings of fruit and veggies) every day really does keep the doctor away—not to mention HPV. A University of Arizona study reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be less protective than vegetables, but are obviously still valuable for good health. Mix it up.
· No smoking. If you smoke, stop it. At once. Smoking increases your risk of developing pre-cancerous lesions by up to a whopping 27 times—yes, times, not percent—perhaps because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. Think I’m just nagging? Check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
· Some supplements MAY help. Astragalus, particularly in the Chinese formula called Jade Screen, can help boost your immune system, as can the bioflavonoid quercetin. Lycopene may also help—the U of A study discovered that women whose blood showed the highest levels of cis-lycopene, found in tomatoes and tomato products, pink grapefruit and watermelon, saw the greatest decrease in risk. Turmeric is good for a lot of things and it’s a great reason to eat curry.
Don’t Sleep Around.
Stop squealing. I grew up in the 60s and 70s, for goodness sake; I’m no prude. But biology is inescapable—ask any of the many women who focused on their careers and put off childbearing until their late 30s and early 40s. Just as fertility really, truly does decline as you get older, so sleeping around really, truly does spread disease. As they say, you have ‘sex’ with every single person each of your partners ever slept with, and women who have sex with two or more partners, particularly at a young age when HPV infection incidence peaks, have a higher risk of developing cervical cancer. A condom helps but it’s very far from foolproof because the virus is spread by skin to skin contact, not, ahem, via bodily fluids. It’s also possible to contract HPV via oral sex. Sorry.
Snip, snip.
Uncircumcised males are more likely to carry HPV. A study published last year in The Journal of Infectious Diseases showed that uncircumcised men are about twice as likely to carry HPV infections, which upped the risk of cervical cancer slightly for their partners. Should you add a caution to your e-Harmony profile, or grill a prospective partner about his foreskin status? I dunno. I’m just telling you the facts.
See, I told you I didn’t have a snake oil cure to help you avoid Gardasil and all its potential side effects. I’ll even say that for some people, especially high-risk people, Gardasil may well be a good idea. This is just what I know so far and what I talk to my daughters about. I’ll update this post as information becomes available.
But talk to your doctor. In general, bloggers raise questions that you may want to get answered and are often the first to stick pins in sacred cows. Sometimes they’re responsible and smart and decent researchers, and sometimes they aren’t. But either way, they’re no substitute for expert advice and medical care. If you don’t trust your doctor, find one you DO trust. Research. Think. Question. But don’t just assume disease only happens to someone else.
So what’s YOUR strategy to avoid or shake off HPV?
But while I struggle with the decision about whether or not to vaccinate my daughters with Gardasil, I’m also trying to figure out an alternative strategy. After all, I don’t much like what I’m hearing about Gardasil, but I also have two people in my life who’ve fallen foul of HPV and have each endured two operations.
Gardasil, like it or loathe it, has focused our attention on the high incidence of HPV, and that’s not a bad thing. If you have some ideas about ways to decrease the risk of pre-cancerous or cancerous lesions forming, please chime in down in the comments section. All of us, not just young girls, need to be aware of ways to protect ourselves.
Just get the check-up, already.
Cervical cancer rates plummeted in the US after women began getting regular check-ups, including Pap smears.
The American Cancer Society currently recommends getting regular screenings by three years after becoming sexually active, or by the age of 21, whichever comes first. (Go to caonline.amcancersoc.org/cgi/content/full/52/6/342 for the full guidelines.) Young women should get smears every one to two years, depending on the test used; women over 30 may be able to switch to every three years.
But although it catches 70- 80 percent of lesions, the Pap smear isn’t infallible. Ask whether you should get an HPV test. And ask in particular about the HPV-DNA test. According to the Journal of the National Cancer Institute, doctors can find about 30 percent more cervical cancer cases when women get a HPV-DNA test before their annual Pap test and then, if they test positive, get another test a year later.
Bottom line: cervical cancer is almost always slow-growing. If you’re one of the unlucky ten percent whose HPV infection turns ugly, you have an extremely good chance of fixing it before cervical cancer develops—as long as you get regular screenings.
Focus on strengthening the host rather than killing the invader.
In other words, pay attention to your general health and immune system. At least 90 percent of all HPV infections clear up by themselves, so be one of the people that simply shrug off infection.
· Eat your carrots. Grandma was right, dammit; an apple (plus some leafy greens, citrus, grapes, tomatoes, broccoli, whatever adds up to 5-10 servings of fruit and veggies) every day really does keep the doctor away—not to mention HPV. A University of Arizona study reported in the journal Cancer Epidemiology, Biomarkers & Prevention found that women who ate a lot of veggies were more than 50 percent less likely to have persistent HPV infections. Fruits and juices appeared to be less protective than vegetables, but are obviously still valuable for good health. Mix it up.
· No smoking. If you smoke, stop it. At once. Smoking increases your risk of developing pre-cancerous lesions by up to a whopping 27 times—yes, times, not percent—perhaps because both smoking and HPV affect the molecules (called cytokines) that control tumor growth. Think I’m just nagging? Check out the study authored by Anthony Gunnell from the Karolinska Institutet in Stockholm, Sweden.
· Some supplements MAY help. Astragalus, particularly in the Chinese formula called Jade Screen, can help boost your immune system, as can the bioflavonoid quercetin. Lycopene may also help—the U of A study discovered that women whose blood showed the highest levels of cis-lycopene, found in tomatoes and tomato products, pink grapefruit and watermelon, saw the greatest decrease in risk. Turmeric is good for a lot of things and it’s a great reason to eat curry.
Don’t Sleep Around.
Stop squealing. I grew up in the 60s and 70s, for goodness sake; I’m no prude. But biology is inescapable—ask any of the many women who focused on their careers and put off childbearing until their late 30s and early 40s. Just as fertility really, truly does decline as you get older, so sleeping around really, truly does spread disease. As they say, you have ‘sex’ with every single person each of your partners ever slept with, and women who have sex with two or more partners, particularly at a young age when HPV infection incidence peaks, have a higher risk of developing cervical cancer. A condom helps but it’s very far from foolproof because the virus is spread by skin to skin contact, not, ahem, via bodily fluids. It’s also possible to contract HPV via oral sex. Sorry.
Snip, snip.
Uncircumcised males are more likely to carry HPV. A study published last year in The Journal of Infectious Diseases showed that uncircumcised men are about twice as likely to carry HPV infections, which upped the risk of cervical cancer slightly for their partners. Should you add a caution to your e-Harmony profile, or grill a prospective partner about his foreskin status? I dunno. I’m just telling you the facts.
See, I told you I didn’t have a snake oil cure to help you avoid Gardasil and all its potential side effects. I’ll even say that for some people, especially high-risk people, Gardasil may well be a good idea. This is just what I know so far and what I talk to my daughters about. I’ll update this post as information becomes available.
But talk to your doctor. In general, bloggers raise questions that you may want to get answered and are often the first to stick pins in sacred cows. Sometimes they’re responsible and smart and decent researchers, and sometimes they aren’t. But either way, they’re no substitute for expert advice and medical care. If you don’t trust your doctor, find one you DO trust. Research. Think. Question. But don’t just assume disease only happens to someone else.
So what’s YOUR strategy to avoid or shake off HPV?
Wednesday, February 4, 2009
Assessing the Side Effects of the Gardasil Vaccine
While I was trying to decipher the possible risk of triggering an autoimmune disease in my kids with a dose or two of Gardasil (see previous post), I got this question stuck in my head. What’s the window? When can you say something could realistically be an adverse event or side effect caused by a vaccine, and when do you toss it back out into the sea of chance?
I got my answer. Six weeks. Unless you’re enrolled in a long-term study, of course—not that any study of Gardasil has thus far been all that lengthy—or unless a pattern becomes truly unmistakable.
So if you drop dead the minute you get a shot, well hot damn, it’s an adverse event. But if you slowly develop rheumatoid arthritis, and get diagnosed a couple of years later, it’s just, well damn. And didn’t your grandma have that anyway? (Let’s not worry about the predisposition/trigger thing.)
Then again, if you drop dead from a blood clot a day after you get Gardasil, and you’re on birth control, well, maybe the CDC will get suspicious and start casting the fish eye over all the other VAERS reports of young healthy women suddenly popping clots. But seven weeks later, definitely blame it on the Pill as a known side-effect, or so I’m told.
And that’s fair enough. At a time when the internet’s being constantly churned by conspiracy theorists and shyster and not-so-shyster lawyers looking to bring multi-million dollar lawsuits, it’s not unreasonable to say, look, we need to be sure that the problem was caused by Vaccine X; we can’t be wandering off into blame-everything-on-it land. And while I do believe that profits play a big role in drug and vaccine development and marketing, I also know that many researchers out there are truly dedicated to “fixing” diseases.
But it reminds me of my mother-in-law laughing at me for buying organic milk. “WE never bothered about any of that nonsense,” she snickered.
And because I can occasionally be kind, I only thought about replying “sure, and you’ve had cancer three times”.
I suspect that any intelligent person could look at Gardasil in isolation and say, as does the CDC, hey, statistically we’re not seeing any more cases of (fill in the blank) than we might reasonably expect in the population.
What I’m wondering is, why do we look at everything in isolation? Isn’t there a pretty strong chance that vaccines could have a cumulative effect as we pile them on? I mean, all I got when I was a kid was the smallpox and oral polio vaccines; for the rest, I just got the disease and got over it. Then we added vaccines against rubella et al; then we got to ditch small pox (yay!) but added a cornucopia of mandatory vaccines. Suddenly hepatitis B was mandatory, wait, add chicken pox, and Prevnar, And what’s that meningitis one for adolescents? Oh, and here’s Gardasil. That’s a good idea. Add Gardasil to the list of recommended vaccines, quick!
That’s an awful lot of foreign bodies and adjuvants zooming into our kids’ systems, along with all the other ingredients of our daily chemical soup slurp.
I wonder about another thing, too. Like all—ahem—midcentury moderns, I vividly remember getting that ugly smallpox vaccine. And wiping out smallpox was undoubtedly a great triumph. But did that vaccine permanently alter the genetic material I passed onto my kids? Will my grandchildren and yours pay a price for generations of multiple vaccines as they’re plagued by ever-rising rates of puzzling auto-immune diseases that can’t specifically be tied to any one cause? Will it be like the statin-diabetes connection, where you fix one thing only to see another—maybe—develop on the cure’s back? Or are all vaccines totally benign?
I honestly don’t know. I’m just curious here, and I’m not an anti-science or anti-medicine nut. But what worries me is that I don’t believe anyone else knows how this all adds up, either.
My only answer, personally, is to do the best I can without getting crazy. So MMR and polio, yes, particularly since we travel overseas, but the chicken pox vaccine seemed unnecessary and my kids survived the disease quite happily. I think Gardasil is unnecessary, too, as long as my daughters get regular check-ups; although I could change my mind if evidence to the contrary becomes clear. So far it’s going in the other direction. But I’ll keep looking.
What about you? Do you think that every vaccination that comes down the pike is good, or do you pick and choose?
I got my answer. Six weeks. Unless you’re enrolled in a long-term study, of course—not that any study of Gardasil has thus far been all that lengthy—or unless a pattern becomes truly unmistakable.
So if you drop dead the minute you get a shot, well hot damn, it’s an adverse event. But if you slowly develop rheumatoid arthritis, and get diagnosed a couple of years later, it’s just, well damn. And didn’t your grandma have that anyway? (Let’s not worry about the predisposition/trigger thing.)
Then again, if you drop dead from a blood clot a day after you get Gardasil, and you’re on birth control, well, maybe the CDC will get suspicious and start casting the fish eye over all the other VAERS reports of young healthy women suddenly popping clots. But seven weeks later, definitely blame it on the Pill as a known side-effect, or so I’m told.
And that’s fair enough. At a time when the internet’s being constantly churned by conspiracy theorists and shyster and not-so-shyster lawyers looking to bring multi-million dollar lawsuits, it’s not unreasonable to say, look, we need to be sure that the problem was caused by Vaccine X; we can’t be wandering off into blame-everything-on-it land. And while I do believe that profits play a big role in drug and vaccine development and marketing, I also know that many researchers out there are truly dedicated to “fixing” diseases.
But it reminds me of my mother-in-law laughing at me for buying organic milk. “WE never bothered about any of that nonsense,” she snickered.
And because I can occasionally be kind, I only thought about replying “sure, and you’ve had cancer three times”.
I suspect that any intelligent person could look at Gardasil in isolation and say, as does the CDC, hey, statistically we’re not seeing any more cases of (fill in the blank) than we might reasonably expect in the population.
What I’m wondering is, why do we look at everything in isolation? Isn’t there a pretty strong chance that vaccines could have a cumulative effect as we pile them on? I mean, all I got when I was a kid was the smallpox and oral polio vaccines; for the rest, I just got the disease and got over it. Then we added vaccines against rubella et al; then we got to ditch small pox (yay!) but added a cornucopia of mandatory vaccines. Suddenly hepatitis B was mandatory, wait, add chicken pox, and Prevnar, And what’s that meningitis one for adolescents? Oh, and here’s Gardasil. That’s a good idea. Add Gardasil to the list of recommended vaccines, quick!
That’s an awful lot of foreign bodies and adjuvants zooming into our kids’ systems, along with all the other ingredients of our daily chemical soup slurp.
I wonder about another thing, too. Like all—ahem—midcentury moderns, I vividly remember getting that ugly smallpox vaccine. And wiping out smallpox was undoubtedly a great triumph. But did that vaccine permanently alter the genetic material I passed onto my kids? Will my grandchildren and yours pay a price for generations of multiple vaccines as they’re plagued by ever-rising rates of puzzling auto-immune diseases that can’t specifically be tied to any one cause? Will it be like the statin-diabetes connection, where you fix one thing only to see another—maybe—develop on the cure’s back? Or are all vaccines totally benign?
I honestly don’t know. I’m just curious here, and I’m not an anti-science or anti-medicine nut. But what worries me is that I don’t believe anyone else knows how this all adds up, either.
My only answer, personally, is to do the best I can without getting crazy. So MMR and polio, yes, particularly since we travel overseas, but the chicken pox vaccine seemed unnecessary and my kids survived the disease quite happily. I think Gardasil is unnecessary, too, as long as my daughters get regular check-ups; although I could change my mind if evidence to the contrary becomes clear. So far it’s going in the other direction. But I’ll keep looking.
What about you? Do you think that every vaccination that comes down the pike is good, or do you pick and choose?
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