Activists were riled last year when vaccination with Gardasil—an alternative HPV vaccine, Cervarix, has not yet been approved in this country—became mandatory for all female immigrants aged 11 to 26 seeking permanent residence in the US.
It’s mandatory because any vaccinations on the government’s ‘recommended’ list automatically become mandatory for immigrants. If Merck succeeds in getting the vaccine on the recommended list for boys and for older women, as it is hoping, then those segments of the immigrant residency-seeking population will also eventually have to fork over the dosh and proffer up their arms.
$360 for the shots, plus the cost of administering them, plus the risk of any side-effects, is not trivial for the average immigrant—particularly when the vaccine is of dubious worth, and when Gardasil is not recommended for anyone who is pregnant. Merck’s data also seems to indicate that it would be unwise to vaccinate with Gardasil if you already have an HPV infection.
“Although ACOG strongly recommends the HPV vaccine, it does not support mandatory HPV vaccination. Prospective immigrant women should have the same opportunity as American women to make an informed decision about whether or not to be vaccinated against HPV,” said the American College of Obstetricians and Gynecologists (ACOG) in a press release.
So, with a letter to the acting director of the CDC, the organization has added its weight to the more than 100 organizations that are asking the CDC and ACIP (the Advisory Committee on Immunization Practices) to remove the HPV vaccine from the list of required vaccinations for would-be residents via a modified recommendation.
Kudos to ACOG for taking a rational stance.
Thursday, February 5, 2009
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?
Monday, February 2, 2009
Gardasil’s Quiet Side-Effect: Autoimmune Disease
Maybe the numbers aren’t statistically significant enough, and with no long-term data we can’t really assess the risk properly. But in one study of 11,813 girls receiving the Gardasil vaccine, 2 developed rheumatoid arthritis, 5 developed arthritis, 1 developed reactive arthritis, and 1 developed juvenile arthritis.
In the control group of similarly-aged young girls, all of whom received placebo shots also containing aluminum, 1 recipient developed lupus and 2 developed arthritis.
Merck has been widely criticized for its use of a placebo containing the same adjuvant as the vaccine instead of a placebo containing a non-reactive saline. Such a practice can mask adverse reactions—although in this case a 3-fold increased risk of auto-immune disease nevertheless became apparent—and aluminum has been associated with nerve cell death.
Multiple cases of the autoimmune disorder Guillain-Barré syndrome arising after vaccination with Gardasil have been reported to the Vaccine Adverse Event Reporting System (it is estimated that less than 10 percent of adverse events are actually reported to VAERS). The CDC, however, has concluded that at least so far there is no evidence that Gardasil increases the risk of Guillain-Barré syndrome.
Heads also swiveled last year over the story of Jenny, a young girl who developed a mystery
case of ALS, motor-neuron disease, after vaccination with Gardasil. Sadly, she was far from the only headline-grabbing "was-it-Gardasil" story.
Incidence of autoimmune disease in general is rising. “Autoimmune disease is a multimillion dollar market set to increase as world prevalence rates rise and the population lives longer,” reported BioPortfolio, rather gleefully.
Roughly eight percent, predominantly women, of people in the US currently suffer various autoimmune diseases that, according to the Lancet, “arise in genetically predisposed individuals but require an environmental trigger.”
Women considering the Gardasil vaccine might want to take hereditary factors into account first.
‘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."’
That seems like a fairly balanced approach to does-it-doesn't-it-cause-auto-immune-disease questions. If you really want to protect against the strains of HPV that cause 70% of cervical cancers, and you’re not willing to count on regular Pap smears to protect you, take a look at your family history before undergoing Gardasil’s three shots. Check for incidence of MS, lupus, rheumatoid arthritis and so on, and then decide.
What do you think? Could Gardasil be a trigger for auto-immune diseases? Does autoimmune disease count as a side-effect of a vaccine if it was triggered by the vaccine rather than caused by it; or if it appears outside the time-frame considered by the CDC? Should we worry about the combined effect of the ever-increasing number of recommended or mandatory vaccines?
In the control group of similarly-aged young girls, all of whom received placebo shots also containing aluminum, 1 recipient developed lupus and 2 developed arthritis.
Merck has been widely criticized for its use of a placebo containing the same adjuvant as the vaccine instead of a placebo containing a non-reactive saline. Such a practice can mask adverse reactions—although in this case a 3-fold increased risk of auto-immune disease nevertheless became apparent—and aluminum has been associated with nerve cell death.
Multiple cases of the autoimmune disorder Guillain-Barré syndrome arising after vaccination with Gardasil have been reported to the Vaccine Adverse Event Reporting System (it is estimated that less than 10 percent of adverse events are actually reported to VAERS). The CDC, however, has concluded that at least so far there is no evidence that Gardasil increases the risk of Guillain-Barré syndrome.
Heads also swiveled last year over the story of Jenny, a young girl who developed a mystery
case of ALS, motor-neuron disease, after vaccination with Gardasil. Sadly, she was far from the only headline-grabbing "was-it-Gardasil" story.
Incidence of autoimmune disease in general is rising. “Autoimmune disease is a multimillion dollar market set to increase as world prevalence rates rise and the population lives longer,” reported BioPortfolio, rather gleefully.
Roughly eight percent, predominantly women, of people in the US currently suffer various autoimmune diseases that, according to the Lancet, “arise in genetically predisposed individuals but require an environmental trigger.”
Women considering the Gardasil vaccine might want to take hereditary factors into account first.
‘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."’
That seems like a fairly balanced approach to does-it-doesn't-it-cause-auto-immune-disease questions. If you really want to protect against the strains of HPV that cause 70% of cervical cancers, and you’re not willing to count on regular Pap smears to protect you, take a look at your family history before undergoing Gardasil’s three shots. Check for incidence of MS, lupus, rheumatoid arthritis and so on, and then decide.
What do you think? Could Gardasil be a trigger for auto-immune diseases? Does autoimmune disease count as a side-effect of a vaccine if it was triggered by the vaccine rather than caused by it; or if it appears outside the time-frame considered by the CDC? Should we worry about the combined effect of the ever-increasing number of recommended or mandatory vaccines?
Friday, January 30, 2009
Gardasil’s Smoking Gun
I dunno, maybe they’ve buried it down in the fine print somewhere, along with that garbled this-medicine-may-cause-you-to-have-ingrown-toenails-and-a-rug-like-Blagojevich stuff, but when the manufacturers of Gardasil are being ever-so-helpful about the nasty prevalence of HPV they’re pretty quiet about smoking.
As in, smoking will make you infinitely more likely to develop cervical cancer. And no, not because you’re puffing away on a Marlboro Light only after a little wanton after-school delight.
Even though the average American parent could be forgiven for believing that if their little darling gets HPV she WILL drop dead of cervical cancer ten minutes later—which is why they should immediately get her vaccinated with Gardasil’s three shot series to the tune of four to six hundred bucks, and hang the side effects—in fact the vast majority of cases of HPV cure themselves.
Or, as the CDC puts it, they’re self-limiting.
But not so much if you’re a smoker. A Swedish study found that smokers were 14 to 27 times (that’s times, not percent) more likely to develop pre-cancerous lesions than non-smokers. That’s because smoking depresses the immune system, and a healthy immune system is what shows HPV the door.
So it seems to me that we should run around slapping 11-12 year-old kids with mandatory courses of Zyban. Just as a preventative, of course.
Seriously. Doesn’t that make about as much sense as vaccinating against something that’s unlikely to develop and is easily cured if it does? (Although, granted, not so easy if you fudge going for regular Pap smears or can’t afford it.)
The Zyban alternative makes particular sense—sort of—when we don’t know how long the Gardasil vaccination will last, don’t know if our kids will need booster shots, don’t know if targeting just a few of the many strains of HPV will cause worse replacement diseases to fill the gap, and good lord, we can’t be bothered to require HPV or pregnancy tests prior to vaccination—despite the fact that Gardasil can, according to Merck’s own research, apparently activate HPV to cause more pre-cancerous lesions. And don’t even think about the risks to fetuses.
Of course, we DO know that auto-immune disease is one of the many possible side-effects of Gardasil, but let’s not talk about that.
Huh.
I think I’m going to take those hundreds of dollars and buy lots of fruits and veggies to bolster the kids’ immune systems instead.
Think our health insurance company would cover that?
Nah. Makes too much sense.
As in, smoking will make you infinitely more likely to develop cervical cancer. And no, not because you’re puffing away on a Marlboro Light only after a little wanton after-school delight.
Even though the average American parent could be forgiven for believing that if their little darling gets HPV she WILL drop dead of cervical cancer ten minutes later—which is why they should immediately get her vaccinated with Gardasil’s three shot series to the tune of four to six hundred bucks, and hang the side effects—in fact the vast majority of cases of HPV cure themselves.
Or, as the CDC puts it, they’re self-limiting.
But not so much if you’re a smoker. A Swedish study found that smokers were 14 to 27 times (that’s times, not percent) more likely to develop pre-cancerous lesions than non-smokers. That’s because smoking depresses the immune system, and a healthy immune system is what shows HPV the door.
So it seems to me that we should run around slapping 11-12 year-old kids with mandatory courses of Zyban. Just as a preventative, of course.
Seriously. Doesn’t that make about as much sense as vaccinating against something that’s unlikely to develop and is easily cured if it does? (Although, granted, not so easy if you fudge going for regular Pap smears or can’t afford it.)
The Zyban alternative makes particular sense—sort of—when we don’t know how long the Gardasil vaccination will last, don’t know if our kids will need booster shots, don’t know if targeting just a few of the many strains of HPV will cause worse replacement diseases to fill the gap, and good lord, we can’t be bothered to require HPV or pregnancy tests prior to vaccination—despite the fact that Gardasil can, according to Merck’s own research, apparently activate HPV to cause more pre-cancerous lesions. And don’t even think about the risks to fetuses.
Of course, we DO know that auto-immune disease is one of the many possible side-effects of Gardasil, but let’s not talk about that.
Huh.
I think I’m going to take those hundreds of dollars and buy lots of fruits and veggies to bolster the kids’ immune systems instead.
Think our health insurance company would cover that?
Nah. Makes too much sense.
Friday, January 23, 2009
HPV Test Plus Pap Versus Gardasil
Well, I’m in. An alternative to Gardasil. Sort of.
As a parent you’re pretty well doomed to feeling worried whatever you do about Gardasil for your daughter.
If you say yes, you’re slightly freaked about possible side effects—paralysis, Guillain-Barré syndrome, that sort of thing.
Not to mention little horrors like, oops, I guess it stopped being effective right around the time she hit the raunchy years. The doctor didn’t mention that. Or, oops, I guess some of the strains of HPV that Gardasil DOESN’T protect against got stronger in the absence of their aggressive older siblings.
Hmmm. There’s a lot of potential oopsies surrounding that expensive little series of shots.
On the other hand, I’m a sucker for commercials. ‘One Less’…doesn’t that sound, well, brave and adventuresome? Like an HBO movie about suffragettes? And if I say no, aren’t I the worst mother in the world, certain to one day find myself sobbing quietly while my daughter nobly tells me it wasn’t my fault as she departs this world? (Or comes down with a nasty case of genital warts—yikes!) After all, THIS IS THE FIRST VACCINE AGAINST CANCER, for God’s sake. Get a grip!
The decision for thinking parents has become so fraught that one mom I know quite literally put her hands over her ears when the subject came up at lunch. “Don’t tell me whatever it is,” she hissed. “We’ve already got her the shots and I just don’t want to know.”
I’ve been withholding judgment pending further research and more news from the front, but I’d more or less decided to nix it anyway. I figure cervical cancer is slow-growing and if she gets her regular Pap smears—which she will need to get anyway—she will, cross-fingers, be OK.
Now I feel even better. According to the Journal of the National Cancer Institute last week, if women who get an HPV-DNA test before their annual Pap test and test positive (got that?) get another test a year later, doctors can find about 30 percent more cases of cervical cancer. Add that to the low risk of HPV developing into cervical cancer, its slow growth, and the dramatic drop in risk for women who get regular Pap smears and I think I can rest assured that my kid is unlikely to get cervical cancer (as long as we have health insurance, anyway.)
Genital warts may be another matter, but we’ll work on that.
Am I being overly optimistic? What do you think?
As a parent you’re pretty well doomed to feeling worried whatever you do about Gardasil for your daughter.
If you say yes, you’re slightly freaked about possible side effects—paralysis, Guillain-Barré syndrome, that sort of thing.
Not to mention little horrors like, oops, I guess it stopped being effective right around the time she hit the raunchy years. The doctor didn’t mention that. Or, oops, I guess some of the strains of HPV that Gardasil DOESN’T protect against got stronger in the absence of their aggressive older siblings.
Hmmm. There’s a lot of potential oopsies surrounding that expensive little series of shots.
On the other hand, I’m a sucker for commercials. ‘One Less’…doesn’t that sound, well, brave and adventuresome? Like an HBO movie about suffragettes? And if I say no, aren’t I the worst mother in the world, certain to one day find myself sobbing quietly while my daughter nobly tells me it wasn’t my fault as she departs this world? (Or comes down with a nasty case of genital warts—yikes!) After all, THIS IS THE FIRST VACCINE AGAINST CANCER, for God’s sake. Get a grip!
The decision for thinking parents has become so fraught that one mom I know quite literally put her hands over her ears when the subject came up at lunch. “Don’t tell me whatever it is,” she hissed. “We’ve already got her the shots and I just don’t want to know.”
I’ve been withholding judgment pending further research and more news from the front, but I’d more or less decided to nix it anyway. I figure cervical cancer is slow-growing and if she gets her regular Pap smears—which she will need to get anyway—she will, cross-fingers, be OK.
Now I feel even better. According to the Journal of the National Cancer Institute last week, if women who get an HPV-DNA test before their annual Pap test and test positive (got that?) get another test a year later, doctors can find about 30 percent more cases of cervical cancer. Add that to the low risk of HPV developing into cervical cancer, its slow growth, and the dramatic drop in risk for women who get regular Pap smears and I think I can rest assured that my kid is unlikely to get cervical cancer (as long as we have health insurance, anyway.)
Genital warts may be another matter, but we’ll work on that.
Am I being overly optimistic? What do you think?
Wednesday, January 14, 2009
Prevnar News Has Worrying Implications for Gardasil
The good news and bad news about Prevnar, Wyeth’s anti-pneumococcal vaccine, may have worrisome implications for Gardasil. Like Gardasil, Prevnar (PCV7) only targets a few selected strains of the pathogen it seeks to vanquish.
The very good news is that since it was adopted as a routine childhood vaccine, rates of a deadly form of meningitis have fallen by 30 percent in children and adults. Because kids no longer pass the disease on to the adults they’re in contact with, they confer a sort of “herd immunity” on those adults.
The bad news is that a team of researchers led by Dr. Lee Harrison of the University of the Pittsburgh School of Medicine found that by 2005 non-PCV7 strains of meningitis had increased by 60.5%. And worse news: the percentage of strains not sensitive to penicillin rose from 19.4 percent in 2003 to 30.1 percent in 2005.
When only selected strains of a pathogen are targeted, a vaccine can create a “replacement disease” as non-targeted strains fill the void and fulfil the principle that “Nature abhors a vacuum.”
Critics of Gardasil have long been concerned that this could happen with the new vaccine, which targets only four of many strains of HPV.
Wyeth, meanwhile, is testing a new version of Prevnar that will cover an additional 13 strains of pneumococcal bacteria. Harrison believes that the new vaccine, if approved, should take care of about half of the disease that remains.
Harrison’s study can be found in the New England Journal of Medicine.
If you are considering having the Gardasil vaccinations, or have already had them, do you think replacement disease is a concern as well as side-effects that may be unknown or under-reported?
The very good news is that since it was adopted as a routine childhood vaccine, rates of a deadly form of meningitis have fallen by 30 percent in children and adults. Because kids no longer pass the disease on to the adults they’re in contact with, they confer a sort of “herd immunity” on those adults.
The bad news is that a team of researchers led by Dr. Lee Harrison of the University of the Pittsburgh School of Medicine found that by 2005 non-PCV7 strains of meningitis had increased by 60.5%. And worse news: the percentage of strains not sensitive to penicillin rose from 19.4 percent in 2003 to 30.1 percent in 2005.
When only selected strains of a pathogen are targeted, a vaccine can create a “replacement disease” as non-targeted strains fill the void and fulfil the principle that “Nature abhors a vacuum.”
Critics of Gardasil have long been concerned that this could happen with the new vaccine, which targets only four of many strains of HPV.
Wyeth, meanwhile, is testing a new version of Prevnar that will cover an additional 13 strains of pneumococcal bacteria. Harrison believes that the new vaccine, if approved, should take care of about half of the disease that remains.
Harrison’s study can be found in the New England Journal of Medicine.
If you are considering having the Gardasil vaccinations, or have already had them, do you think replacement disease is a concern as well as side-effects that may be unknown or under-reported?
FDA Weighs Gardasil for Boys and Men
Note: If you are interested in Gardasil for boys and men, please see more recent posts:
here (9/9/09) and here (9/10/09)
FDA Weighs Gardasil for Boys and Men
In late December pharmaceutical giant Merck filed for FDA approval to market its controversial Gardasil vaccine to boys and men.
The move was not unexpected, given that a Merck study of 4,000 boys ages 16 to 26 showed Gardasil to be effective in preventing 90 percent of cases of penile cancer and genital warts, caused by the same four strains of HPV that currently cause 70 percent of cases of cervical cancer.
The FDA will take up to two months to decide whether Merck’s application meets its standards; it could then take ten months or more to review the data.
Although Merck might have a tough job persuading heterosexual males to undergo the expensive and painful series of shots, homosexual men are expected to be a big market as Gardasil may well be an effective weapon against anal cancer.
Presumably men will experience the same side effects of the shots as women. Gardasil has been associated with Guillain-Barré Syndrome, pancreatitis, seizures, paralysis and blood clots in the heart, lungs, and legs, among other issues: the majority of side effects reported to VAERS thus far, however, are pain at the injection site and fainting.
Gardasil is currently being marketed to girls as young as nine. The CDC recommends that it be routinely given to 11 and 12 year-olds or before sexual activity begins.
Merck’s stock is still down after the FDA denied its application for Gardasil to be marketed to older women, citing the need for further data and completion of a 48-month study. MRK is trading at less than half of its one year high.
What do you think? Would you get Gardasil’s 3-shot vaccine for your sons? Or have you yourself, or your daughter, experienced any side effects from the shot?
here (9/9/09) and here (9/10/09)
FDA Weighs Gardasil for Boys and Men
In late December pharmaceutical giant Merck filed for FDA approval to market its controversial Gardasil vaccine to boys and men.
The move was not unexpected, given that a Merck study of 4,000 boys ages 16 to 26 showed Gardasil to be effective in preventing 90 percent of cases of penile cancer and genital warts, caused by the same four strains of HPV that currently cause 70 percent of cases of cervical cancer.
The FDA will take up to two months to decide whether Merck’s application meets its standards; it could then take ten months or more to review the data.
Although Merck might have a tough job persuading heterosexual males to undergo the expensive and painful series of shots, homosexual men are expected to be a big market as Gardasil may well be an effective weapon against anal cancer.
Presumably men will experience the same side effects of the shots as women. Gardasil has been associated with Guillain-Barré Syndrome, pancreatitis, seizures, paralysis and blood clots in the heart, lungs, and legs, among other issues: the majority of side effects reported to VAERS thus far, however, are pain at the injection site and fainting.
Gardasil is currently being marketed to girls as young as nine. The CDC recommends that it be routinely given to 11 and 12 year-olds or before sexual activity begins.
Merck’s stock is still down after the FDA denied its application for Gardasil to be marketed to older women, citing the need for further data and completion of a 48-month study. MRK is trading at less than half of its one year high.
What do you think? Would you get Gardasil’s 3-shot vaccine for your sons? Or have you yourself, or your daughter, experienced any side effects from the shot?
Subscribe to:
Posts (Atom)
