Governor Jerry Brown’s failure to veto California’s new anti-STD law—allowing clinics to give Gardasil shots to children without their parents’ knowledge or permission—could have a dangerous side effect.
Say your kid started having seizures. If you didn’t know he’d been given a vaccine, it wouldn’t even cross your mind to file a VAERS (vaccine adverse event reporting system) report. Nor would you think to contact the vaccine manufacturer.
VAERS is already notoriously fallible. Although those searching it are wont to say, “Look! It says on VAERS that x number of people have—died, acquired a seizure disorder or an autoimmune disease, whatever— from Gardasil!” that’s rarely the case. Doctors and individuals report anything they believe MIGHT be a side effect or adverse event related to the HPV vaccine, and the scientists of VAERS and the FDA are supposed to follow up and try to determine patterns that bear investigation. Many ‘side effects’ are reported. Some will inevitable turn out to have nothing to do with a vaccine, or not as far as the FDA can determine at this point, anyway.
Equally, events that could be related to Gardasil frequently go unreported because a doctor refuses, or sees no need, to make a report. Or maybe a parent fails to connect the dots and ask questions. Look at Jenny Tetlock’s case—her parents turned up two rare and virtually identical cases that hadn’t been reported. Like I said, VAERS is fallible.
And are these busy clinics really going to monitor the health of the kids they are merrily giving the shot to? For months, a year, more? File VAERS reports on anything that seems odd so that the FDA's records are complete? Doesn't seem likely, does it?
I can't think of any other vaccine that has been gifted with such potentially lax oversight.
Here I should say that there is as yet no official link between seizures and Gardasil yet, although the anecdotal evidence is mounting and the FDA is apparently beginning to investigate it more thoroughly (see here).
But how can the FDA even properly begin to make possible connections between Gardasil and seizures, or Gardasil and autoimmune disease, or Gardasil and blood clots, when VAERS reporting is limited even more?
Oh, wait….
Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts
Thursday, October 13, 2011
Tuesday, October 4, 2011
Why Governor Jerry Brown should veto pro-Gardasil AB 499
Presidential hopeful Rick Perry got into an awful lot of trouble for trying to mandate Gardasil, the HPV vaccine. But at least parents would have had the chance to opt out for religious or other reasons.
AB 499, which has been passed by California’s legislature and is now awaiting a yay or nay from Governor Brown, not only doesn’t offer an opt-out, it also ensures that parents may not even know if their son or daughter has had the vaccine. I’ve got to hand it to Merck; that’s an absolutely brilliant way to ensure that potential side effects and adverse events aren’t reported for study.
Here’s the thing that shocks the heck out of me. I’ve had tons of people try to badger me into getting Gardasil for my daughters, including pediatricians and gynecologists. And, frankly, it always turns out that I know more about the vaccine and HPV than they do.
“It’s almost 100 percent successful in preventing HPV infection,” they say. Sure—for the two oncogenic strains it contains, but not for those that currently cause some 34 percent of cervical cancers, nor for any that might fill the biological niche left by the vanquished strains. And the latest results show an overall 17-45 percent reduction in cervical abnormalities, not 100 percent. “Really?” they say.
Uh, yes.(Shouldn’t you KNOW this?)
Maybe I’m old-fashioned, but I believe that being fully informed means…being fully informed, both as the giver and as the receiver of the HPV vaccine, or any other healthcare choice. That’s the basis for intelligent decisions.
Yet if AB 499 becomes law, some spotty little twerp who doesn’t even know that smoking hugely ups the chances of getting a persistent HPV infection—or, for that matter, why the word ‘persistent’ is important—can pull the HPV vaccine trigger on a 12 year old. The kid won’t be considered smart enough to have a beer for another 9 years, mind you, but somehow he’s smart enough to completely understand, and consent to, the risks and rewards of a vaccine. Right now. Oh, and of course he’s confident enough to say ‘no’ to a doctor if he weighs the risks and rewards and decides against it.
Yeah, sure.
So I’m one of those 'crazy anti-vaxxers,' right?
I fully expected to get Gardasil for my kids when it came out. But I'm a parent. So I researched and thought carefully about our options. What I found was that there is a lot of anecdotal information about autoimmune disease being triggered, a plausible theory backed by a reputable study about why this might be so, pause for thought in Merck’s own studies; and strong evidence that Merck’s marketing machine has emphasized the risks of HPV, completely ignored the role of individual lifestyle choice, and minimized potential risks of the vaccine.
And as The Lancet puts it, autoimmune diseases “arise in genetically predisposed individuals but require an environmental trigger.”
My kids have a family history of autoimmune disease, specifically MS. One child has already been diagnosed with Raynaud’s disease, which could be something or nothing. We try to keep the environmental triggers to a minimum. So, as a parent, I made an informed choice to get the kids Menactra to avoid a rare but terrifying disease, but nixed the Gardasil, which seems largely unnecessary for our particular family. (We eat our veggies, don’t smoke, get the whole healthy immune system thing, and understand the importance of regular Pap smears.)
Our choice, and one that we have every right to make. Other families with different circumstances and habits might well, even SHOULD, make a different choice. This is America, right?
Governor Brown has already taken steps against a circumcision ban—ironically, circumcision is proven to help reduce the spread of HPV—and vetoed a ski-helmet law on the basis that parents have the right and the ability to make reasonable choices for their children. So let’s hope good things come in threes.
And Planned Parenthood should be ashamed of itself, too.
Me, I’m Planned Parenthood’s dream. I’m socially liberal. We have health insurance, so we don’t use their services, but I’ve always donated so that people who don’t have health insurance have options too.
I don’t run screaming at the very idea of my kids having sex, although I’ve given them The Lecture about rights and responsibilities, physical, emotional and spiritual.
I’ll talk to them about anything and frequently do, much to their horror. (Particularly, it must be said, after a large g & t. Yum—Hendricks or Cardinal gin. Eat your heart out, Big Brands!)
If they want to go to a gynecologist, I’ll drive them there, pay the bill, and stay out of the room while they’re talking. But again, I understand that some kids, maybe even mine, can’t discuss some things with their parents. Although it pains me to think it’s necessary, I do think PP needs to provide services to kids so that they can be marginally more intelligent about the choices teenagers are wont to make.
But the organization’s arrogant support of AB 499 is going way too far for me. So Planned Parenthood is quite literally off MY Christmas list.
No perfect choices.
It’s quite possible that in 10, 20, 30 years one of my kids will be one of the tiny minority of women who suffer the effects of a persistent HPV infection, and I’ll bitterly regret my choice. It’s also quite possible that if I gave it to them I would be one of the tiny minority of parents who bitterly regret saying yes to Gardasil, like the Tetlocks or the Tarsells.
There’s no perfect choice. As a parent, I make lots of probably imperfect, but informed and thoughtful, choices. And guess what, Assemblywoman Toni Atkins and the policy makers of Planned Parenthood?
It’s none of your damn business.
Friday, July 29, 2011
Gardasil vaccines tainted by debris
Let the PR begin. Merck says it isn’t aware of any ‘adverse events’ stemming from bits of charred shrink wrap found in some vials of Gardasil, Varivax and Pneumovax; of course, the pharma company didn’t think any had stemmed from previous problems with metal particle contamination or cracked vials, either.
Not that it would have necessarily rushed to tell the FDA about problems anyway. The FDA saw fit to give Merck a rap over the knuckles for delaying adverse event reporting—something that readers of this blog have complained about endlessly after bad experiences. And according to Merck, the worst that recipients of one of years' worth of tainted vaccines can expect is injection site irritation. They know this how, exactly?
Still, you can rest easy.
“What we are seeing is that the severity and criticality of observations [by FDA inspectors] are declining,” James Robinson, vice president of vaccines product and technical operations, told the Wall Street Journal. “What we’ve seen in the last few inspections tells us we’re on the right track.”
Gosh. That makes me feel a whole lot better about the potential for one of my kids having a particle of metal or burned plastic injected into her flesh, and thence her system. Things are better than they were! Who needs perfect?
Just repeat after me: it’s statistically insignificant, and so is anything you might suffer afterwards.
Meanwhile, my daughter needs a tetnus booster. Guess I'd better go along to check for cracked vials and to cross my fingers about contamination.
Not that it would have necessarily rushed to tell the FDA about problems anyway. The FDA saw fit to give Merck a rap over the knuckles for delaying adverse event reporting—something that readers of this blog have complained about endlessly after bad experiences. And according to Merck, the worst that recipients of one of years' worth of tainted vaccines can expect is injection site irritation. They know this how, exactly?
Still, you can rest easy.
“What we are seeing is that the severity and criticality of observations [by FDA inspectors] are declining,” James Robinson, vice president of vaccines product and technical operations, told the Wall Street Journal. “What we’ve seen in the last few inspections tells us we’re on the right track.”
Gosh. That makes me feel a whole lot better about the potential for one of my kids having a particle of metal or burned plastic injected into her flesh, and thence her system. Things are better than they were! Who needs perfect?
Just repeat after me: it’s statistically insignificant, and so is anything you might suffer afterwards.
Meanwhile, my daughter needs a tetnus booster. Guess I'd better go along to check for cracked vials and to cross my fingers about contamination.
Wednesday, September 22, 2010
Seventeen Magazine’s ‘Scary Sex Rumors’ about the Gardasil HPV Vaccine
Ouch. Seventeen Magazine gets both a carrot and a stick for its September 2010 issue’s ‘Scary Sex Rumors’ item about Gardasil.
Addressing the ‘rumors’ and forwarded emails about how “the HPV vaccine has been killing teenage girls!!” the venerable teen magazine came up with both some sensible advice and some scary sex rumors of its own.
I applaud the writer for noting that “The bottom line is, any vaccine can have some risks, and you need to weigh those risks against the risks of skipping it…talk to your doc, who can help you decide.”
Although most doctors know very little about Gardasil beyond the standard information, still, I like the advice to discuss the HPV vaccine—not just automatically get it—and the acknowledgement that there’s a balance between risks and rewards for each individual, depending on lifestyle and family history.
And I can’t exactly argue with the line “while there have been rare reports of scary side effects, like seizures, they haven’t been directly linked to Gardasil.” They haven’t. While there are some mighty coincidental cases of seizures following Gardasil ( and see here), we’re simply in the follow-up phase where the FDA continues to monitor reports of adverse events like Graves Disease, lupus, Guillain-Barre, ALS, etc., until they can see statistical differences between vaccinated and unvaccinated populations. So far, there have been no links.
I do have to say here that monitoring, of course, involves people taking the initiative to make a report to VAERS even when discouraged by their doctors. It’s thought that potential side effects are both under-reported and over-reported—under-reported because people usually don’t connect the dots unless an adverse event happens immediately; such under-reporting may happen frequently (consider the Jenny Tetlock case, where Ms. Tetlock’s parents discovered two very similar cases of a rapid-onset ALS-type disease that had gone unreported). And side effects may also be over-reported—for instance, at least one of the deaths attributed to Gardasil was due to a car accident, and to the best of my knowledge not because the driver was seizing post-vaccination.
So if you get a vaccine, and then, say, an autoimmune disease, please report it whether you or your doctor think it’s relevant or not. The FDA will sort it out and they can only assess adverse events properly when they’re fully informed .
But where I get angry—actually, really angry—is when I see this sentence. “The chances of having a serious problem are really unlikely (less than 2 in 10,000) but the risk of getting HPV in your lifetime is huge (8 in 10).”
True, 80 percent of women will catch some strain of HPV during their lifetime. What the writer doesn’t mention is that as many as 95 percent of infections are shrugged off by the immune system, leaving behind, it’s thought, a natural immunity. Nor does s/he mention that behaviors such as smoking and poor diet seriously up the risk of an infection becoming persistent and therefore potentially leading to cervical abnormalities, even cervical cancer. Nor does s/he note that because not all oncogenic strains of HPV are included in the vaccine, it’s essential to continue regular gynecological exams. Thus far, trials show overall reductions of anywhere from 17 to 45 percent in colposcopies, cervical abnormalities, etc.
Nope, Seventeen echoes Merck’s marketing campaign, which vastly exaggerates the risks of HPV and minimizes the risks of the vaccine, and doesn’t mention behavioral risks (as in, heavy smokers are 27 TIMES more likely to suffer cervical abnormalities) at all. The implication is that you're highly likely to get cervical cancer if you don't get Gardasil and virtually certain not to get it if you do.
Now that’s a scary sex rumor.
Addressing the ‘rumors’ and forwarded emails about how “the HPV vaccine has been killing teenage girls!!” the venerable teen magazine came up with both some sensible advice and some scary sex rumors of its own.
I applaud the writer for noting that “The bottom line is, any vaccine can have some risks, and you need to weigh those risks against the risks of skipping it…talk to your doc, who can help you decide.”
Although most doctors know very little about Gardasil beyond the standard information, still, I like the advice to discuss the HPV vaccine—not just automatically get it—and the acknowledgement that there’s a balance between risks and rewards for each individual, depending on lifestyle and family history.
And I can’t exactly argue with the line “while there have been rare reports of scary side effects, like seizures, they haven’t been directly linked to Gardasil.” They haven’t. While there are some mighty coincidental cases of seizures following Gardasil ( and see here), we’re simply in the follow-up phase where the FDA continues to monitor reports of adverse events like Graves Disease, lupus, Guillain-Barre, ALS, etc., until they can see statistical differences between vaccinated and unvaccinated populations. So far, there have been no links.
I do have to say here that monitoring, of course, involves people taking the initiative to make a report to VAERS even when discouraged by their doctors. It’s thought that potential side effects are both under-reported and over-reported—under-reported because people usually don’t connect the dots unless an adverse event happens immediately; such under-reporting may happen frequently (consider the Jenny Tetlock case, where Ms. Tetlock’s parents discovered two very similar cases of a rapid-onset ALS-type disease that had gone unreported). And side effects may also be over-reported—for instance, at least one of the deaths attributed to Gardasil was due to a car accident, and to the best of my knowledge not because the driver was seizing post-vaccination.
So if you get a vaccine, and then, say, an autoimmune disease, please report it whether you or your doctor think it’s relevant or not. The FDA will sort it out and they can only assess adverse events properly when they’re fully informed .
But where I get angry—actually, really angry—is when I see this sentence. “The chances of having a serious problem are really unlikely (less than 2 in 10,000) but the risk of getting HPV in your lifetime is huge (8 in 10).”
True, 80 percent of women will catch some strain of HPV during their lifetime. What the writer doesn’t mention is that as many as 95 percent of infections are shrugged off by the immune system, leaving behind, it’s thought, a natural immunity. Nor does s/he mention that behaviors such as smoking and poor diet seriously up the risk of an infection becoming persistent and therefore potentially leading to cervical abnormalities, even cervical cancer. Nor does s/he note that because not all oncogenic strains of HPV are included in the vaccine, it’s essential to continue regular gynecological exams. Thus far, trials show overall reductions of anywhere from 17 to 45 percent in colposcopies, cervical abnormalities, etc.
Nope, Seventeen echoes Merck’s marketing campaign, which vastly exaggerates the risks of HPV and minimizes the risks of the vaccine, and doesn’t mention behavioral risks (as in, heavy smokers are 27 TIMES more likely to suffer cervical abnormalities) at all. The implication is that you're highly likely to get cervical cancer if you don't get Gardasil and virtually certain not to get it if you do.
Now that’s a scary sex rumor.
Monday, September 13, 2010
Gardasil and seizures: is VAERS now taking a connection seriously?
Theresa E was floored when she got a phone call from VAERS, the FDA’s vaccine adverse event reporting system. Yes, the caller said, investigators did indeed feel that Theresa’s daughter’s seizures could be a serious reaction to Merck’s anti-HPV vaccine, Gardasil.
Although Theresa had had a hunch that her daughter’s intermittent seizures could have been triggered by the Gardasil vaccine, doctors completely pooh-poohed the idea.
But eventually, encouraged by information from Nina Kenney, whose daughter had also begun suffering seizures post-vaccine, she insisted on filing a VAERS report. Her doctor had for months been “too busy” to get around to the paperwork, she said, “and when I took the almost-completed form to him to finish he was a little shocked that I was serious.”
So when someone from VAERS called shortly afterwards to verify the information she’d provided and made the comment about a serious reaction, Theresa was so stunned that she asked her caller to repeat it. She’s relieved to see that taking the time to report to VAERS was worthwhile; her information will add to what investigators know.
Yes, report post-vaccine seizures—even if your doctor discourages you
"If I can prevent one more person from getting hurt, it’s all worth it. Please encourage people to send as much concrete information to VAERS as possible, because I think that’s why they listened. I didn’t just send the form. There isn’t enough space on the form to give much info, so they got a two-page letter, copies of the school report about where they found my daughter and letters stating that the (Gardasil) vaccines were stored improperly. I felt I was sending too much info, but I am glad I did. Whether it is an active ingredient or an inactive ingredient, they need to find out for sure.”
None of this is to say that there is now a proven connection between Gardasil and seizures: there isn’t, or at least, not at this point. Teenagers do develop epilepsy and seizure disorders with or without Gardasil. But when seizures follow vaccination in multiple cases, medical investigators need to—well, investigate. That’s what the FDA is supposed to do. And, thank God, they’re now doing it.
Do neurologists ask about pre-seizure vaccinations yet?
In February 2009, Gardasil vaccinations were briefly suspended in Spain after three unrelated incidents in which girls began suffering repeated convulsions hours after being vaccinated with the HPV vaccine. Eventually, authorities determined that the vaccine might have triggered, but not caused, the convulsions—a distinction that still eludes me in practical terms—largely because there were few similar cases on the books. (See here). With the best will in the world, investigators can’t reconcile correlation and causation without enough data. So just make the reports, already.
After a young girl, Jenny Tetlock, died post-Gardasil vaccination from a highly unusual ALS/autoimmune-type disease mediated by immune response, her neurologist, knowing of at least one similar case, announced to fellow neurologists that she planned to make a study of girls with ALS-type diseases (see here). Finding any such cases requires that neurologists make a habit of asking patients whether they got the vaccine.
There are so many cases of post-Gardasil seizures that surely it would be smart to call on neurologists seeing new seizure patients to ask them that question, too. Just ask the question—did you get Gardasil? Menactra? Adacel? Together or separately?—and file any appropriates reports with VAERS. Then, if there’s a connection, we’ll know.
Theresa’s daughter got her first Gardasil shot, along with Menactra, in July 2009. She suffered a commotion-causing ‘sleepwalking’ episode in her dorm in August and a second episode after the second shot. Theresa believes that both episodes were really seizures as her daughter was disoriented and appeared to observers to be on drugs; the second time the teenager recalls feeling twitchy and exhausted (common post-seizure symptoms) afterwards. Then her parents actually witnessed her seizing while they were all on vacation. The experience was devastating, but at least they finally knew was wrong. Now in her second year of college, she’s been diagnosed with a nocturnal seizure disorder and is taking Keppra twice daily.
Drugged, drunk—or seizing?
The drugged appearance is all too familiar to Nina. “I’ve never seen Nora seize, but a few weeks ago I saw her right after a seizure. She was extremely disoriented, and in fact I thought she was drunk. She was very perturbed as well. Flat out mean. She tells me this behavior is a common factor with her seizures. She has yelled at paramedics and anyone who's nearby right afterward. Furthermore, she has no memory of the seizure and often, the entire day leading up to the seizure. Post seizure, she's exhausted and has a terrible headache for a day or two afterward.”
When Theresa witnessed her daughter’s seizure on vacation, “our daughter did appear to be drunk or really out of it; she could not correctly answer the questions for paramedics after the seizure. After a bit, she did.”
Which makes one wonder whether some seizures go undiagnosed because the usual reaction to a young adult who appears to be drunk or drugged is an eye-rolling “kids will be kids.”
“As far as the MRI and EEG,” says Nina, “Nora's MRI and CT scan have been normal. She's only had one EEG and, according to the first neurologist she saw, it showed a 'slight abnormality'. I think he used the term compact partial seizure.”
The ER doctor’s diagnosis after Nora’s first seizure was syncope/dehydration because he attributed the episode to alcohol consumption the day before—even though the episode included severe tongue-biting, “a classic seizure symptom,” according to the neurologist Nora later saw. When she seized again after her second Gardasil shot, however, the final diagnosis was Epileptic Seizures, and her VAERS report now shows it as a “positive vaccine re-challenge”—which basically means that the same symptoms, or worse symptoms, presented themselves with the second shot, making a connection highly plausible. Nora did not get the third shot.
Two girls, two different VAERS responses, two years apart
Nina had a very different experience with reporting Nora’s seizures to VAERS two years ago.
When she made the connection between Gardasil and Nora’s seizures, she faxed a letter to Nora’s neurologist, sent another to the pediatrician, filed an online VAERS report, called Merck, filed an online report with Sanofli-Pasteur (because Nora had also received a Menactra shot with her first Gardasil shot), and filed an online report with the NVIC. Only the NVIC and the pediatrician responded.
A few months later, Emily Tarsell, whose daughter Chris died of still-unknown causes after receiving the Gardasil vaccination, suggested that Nina contact the FDA for the Gardasil lot numbers and reports. When the reports arrived, Nina discovered that Nora’s VAERS report seemed to include Nora among the girls who fainted upon getting the shot, probably because of the ER report after the first episode. She immediately faxed VAERS a letter; they contacted her only to get her neurologist’s contact information and left the report essentially unchanged.
Only after Nina sent a strongly-worded letter to the Vaccines and Related Biological Products Advisory Committee, prior to their meeting to decide whether to approve Gardasil for boys, did VAERS actually contact her for a timeline of events and further information. Nina’s letter had commented that a year after she’d made all those reports, no-one had bothered to contact her. Two weeks later, she heard from VAERS. After an entire year.
It bears repeating: Gardasil is not proven to cause seizures in susceptible individuals. If you're considering Gardasil for yourself of your child, you and your doctor need to honestly discuss its pros and cons given your individual circumstances and family health history.
But, “I subscribe to the Epilepsy Foundation site's parent community,” says Nina, “and there are MANY members whose seizures started after Gardasil. So in spite of what most in the medical community say, I believe there's a connection.”
And it appears that if there is one, the FDA's finally started seriously looking for it. So do your part. If your child's seizures began only after an adolescent vaccination of any kind, file the report. With or without the help and/or encouragement of your doctor.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Although Theresa had had a hunch that her daughter’s intermittent seizures could have been triggered by the Gardasil vaccine, doctors completely pooh-poohed the idea.
But eventually, encouraged by information from Nina Kenney, whose daughter had also begun suffering seizures post-vaccine, she insisted on filing a VAERS report. Her doctor had for months been “too busy” to get around to the paperwork, she said, “and when I took the almost-completed form to him to finish he was a little shocked that I was serious.”
So when someone from VAERS called shortly afterwards to verify the information she’d provided and made the comment about a serious reaction, Theresa was so stunned that she asked her caller to repeat it. She’s relieved to see that taking the time to report to VAERS was worthwhile; her information will add to what investigators know.
Yes, report post-vaccine seizures—even if your doctor discourages you
"If I can prevent one more person from getting hurt, it’s all worth it. Please encourage people to send as much concrete information to VAERS as possible, because I think that’s why they listened. I didn’t just send the form. There isn’t enough space on the form to give much info, so they got a two-page letter, copies of the school report about where they found my daughter and letters stating that the (Gardasil) vaccines were stored improperly. I felt I was sending too much info, but I am glad I did. Whether it is an active ingredient or an inactive ingredient, they need to find out for sure.”
None of this is to say that there is now a proven connection between Gardasil and seizures: there isn’t, or at least, not at this point. Teenagers do develop epilepsy and seizure disorders with or without Gardasil. But when seizures follow vaccination in multiple cases, medical investigators need to—well, investigate. That’s what the FDA is supposed to do. And, thank God, they’re now doing it.
Do neurologists ask about pre-seizure vaccinations yet?
In February 2009, Gardasil vaccinations were briefly suspended in Spain after three unrelated incidents in which girls began suffering repeated convulsions hours after being vaccinated with the HPV vaccine. Eventually, authorities determined that the vaccine might have triggered, but not caused, the convulsions—a distinction that still eludes me in practical terms—largely because there were few similar cases on the books. (See here). With the best will in the world, investigators can’t reconcile correlation and causation without enough data. So just make the reports, already.
After a young girl, Jenny Tetlock, died post-Gardasil vaccination from a highly unusual ALS/autoimmune-type disease mediated by immune response, her neurologist, knowing of at least one similar case, announced to fellow neurologists that she planned to make a study of girls with ALS-type diseases (see here). Finding any such cases requires that neurologists make a habit of asking patients whether they got the vaccine.
There are so many cases of post-Gardasil seizures that surely it would be smart to call on neurologists seeing new seizure patients to ask them that question, too. Just ask the question—did you get Gardasil? Menactra? Adacel? Together or separately?—and file any appropriates reports with VAERS. Then, if there’s a connection, we’ll know.
Theresa’s daughter got her first Gardasil shot, along with Menactra, in July 2009. She suffered a commotion-causing ‘sleepwalking’ episode in her dorm in August and a second episode after the second shot. Theresa believes that both episodes were really seizures as her daughter was disoriented and appeared to observers to be on drugs; the second time the teenager recalls feeling twitchy and exhausted (common post-seizure symptoms) afterwards. Then her parents actually witnessed her seizing while they were all on vacation. The experience was devastating, but at least they finally knew was wrong. Now in her second year of college, she’s been diagnosed with a nocturnal seizure disorder and is taking Keppra twice daily.
Drugged, drunk—or seizing?
The drugged appearance is all too familiar to Nina. “I’ve never seen Nora seize, but a few weeks ago I saw her right after a seizure. She was extremely disoriented, and in fact I thought she was drunk. She was very perturbed as well. Flat out mean. She tells me this behavior is a common factor with her seizures. She has yelled at paramedics and anyone who's nearby right afterward. Furthermore, she has no memory of the seizure and often, the entire day leading up to the seizure. Post seizure, she's exhausted and has a terrible headache for a day or two afterward.”
When Theresa witnessed her daughter’s seizure on vacation, “our daughter did appear to be drunk or really out of it; she could not correctly answer the questions for paramedics after the seizure. After a bit, she did.”
Which makes one wonder whether some seizures go undiagnosed because the usual reaction to a young adult who appears to be drunk or drugged is an eye-rolling “kids will be kids.”
“As far as the MRI and EEG,” says Nina, “Nora's MRI and CT scan have been normal. She's only had one EEG and, according to the first neurologist she saw, it showed a 'slight abnormality'. I think he used the term compact partial seizure.”
The ER doctor’s diagnosis after Nora’s first seizure was syncope/dehydration because he attributed the episode to alcohol consumption the day before—even though the episode included severe tongue-biting, “a classic seizure symptom,” according to the neurologist Nora later saw. When she seized again after her second Gardasil shot, however, the final diagnosis was Epileptic Seizures, and her VAERS report now shows it as a “positive vaccine re-challenge”—which basically means that the same symptoms, or worse symptoms, presented themselves with the second shot, making a connection highly plausible. Nora did not get the third shot.
Two girls, two different VAERS responses, two years apart
Nina had a very different experience with reporting Nora’s seizures to VAERS two years ago.
When she made the connection between Gardasil and Nora’s seizures, she faxed a letter to Nora’s neurologist, sent another to the pediatrician, filed an online VAERS report, called Merck, filed an online report with Sanofli-Pasteur (because Nora had also received a Menactra shot with her first Gardasil shot), and filed an online report with the NVIC. Only the NVIC and the pediatrician responded.
A few months later, Emily Tarsell, whose daughter Chris died of still-unknown causes after receiving the Gardasil vaccination, suggested that Nina contact the FDA for the Gardasil lot numbers and reports. When the reports arrived, Nina discovered that Nora’s VAERS report seemed to include Nora among the girls who fainted upon getting the shot, probably because of the ER report after the first episode. She immediately faxed VAERS a letter; they contacted her only to get her neurologist’s contact information and left the report essentially unchanged.
Only after Nina sent a strongly-worded letter to the Vaccines and Related Biological Products Advisory Committee, prior to their meeting to decide whether to approve Gardasil for boys, did VAERS actually contact her for a timeline of events and further information. Nina’s letter had commented that a year after she’d made all those reports, no-one had bothered to contact her. Two weeks later, she heard from VAERS. After an entire year.
It bears repeating: Gardasil is not proven to cause seizures in susceptible individuals. If you're considering Gardasil for yourself of your child, you and your doctor need to honestly discuss its pros and cons given your individual circumstances and family health history.
But, “I subscribe to the Epilepsy Foundation site's parent community,” says Nina, “and there are MANY members whose seizures started after Gardasil. So in spite of what most in the medical community say, I believe there's a connection.”
And it appears that if there is one, the FDA's finally started seriously looking for it. So do your part. If your child's seizures began only after an adolescent vaccination of any kind, file the report. With or without the help and/or encouragement of your doctor.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Wednesday, August 25, 2010
Worrisome Gardasil side effect: cervical cancer screening rates drop significantly
The number of young women getting regular Pap tests has dropped quite significantly in Australia, where Merck’s Gardasil vaccine has been administered to almost all girls aged 12-13 via a school-based program. Women up to the age of 26 have also been able to receive the three-shot HPV vaccine free of charge through a now-ended catch-up program.
Health authorities are concerned about the ten percent drop in screenings among 25-29 year olds. The problem, they believe, may be that young women have been “lulled into a false sense of security” by Gardasil, which is advertised as a vaccine against cervical cancer.
Merck’s human papillomavirus vaccine actually only protects against the two HPV strains that cause 65-70 percent of cervical cancer, so it’s essential that women continue to get regular screenings. It’s particularly important because replacement disease, whereby other strains of the virus fill the biological niche left by the two vaccine-relevant strains, may well become an issue. And so far, although the vaccine has proved very effective against the vaccine-relevant strains, overall cervical abnormality rates have dropped by only 17-45 percent.
Regular Pap smears alone can eliminate at least 90 percent of cervical cancers. When a woman gets an HPV test along with the smear, there’s very little chance that cervical cancer will sneak up on her. (See here .) Women are advised to go for screenings every 1-3 years; screenings are also important because doctors will usually check for breast cancer and other health issues at the same time.
All in all, it’s hardly surprising that Australian health officials are "concerned." And if you or your daughter have had the Gardasil shots and have shelved regular exams, well, don't, is all I can say.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Health authorities are concerned about the ten percent drop in screenings among 25-29 year olds. The problem, they believe, may be that young women have been “lulled into a false sense of security” by Gardasil, which is advertised as a vaccine against cervical cancer.
Merck’s human papillomavirus vaccine actually only protects against the two HPV strains that cause 65-70 percent of cervical cancer, so it’s essential that women continue to get regular screenings. It’s particularly important because replacement disease, whereby other strains of the virus fill the biological niche left by the two vaccine-relevant strains, may well become an issue. And so far, although the vaccine has proved very effective against the vaccine-relevant strains, overall cervical abnormality rates have dropped by only 17-45 percent.
Regular Pap smears alone can eliminate at least 90 percent of cervical cancers. When a woman gets an HPV test along with the smear, there’s very little chance that cervical cancer will sneak up on her. (See here .) Women are advised to go for screenings every 1-3 years; screenings are also important because doctors will usually check for breast cancer and other health issues at the same time.
All in all, it’s hardly surprising that Australian health officials are "concerned." And if you or your daughter have had the Gardasil shots and have shelved regular exams, well, don't, is all I can say.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Tuesday, May 25, 2010
So who’s reporting Gardasil to the FDA’s Bad Ad program?
I’m sure this makes me a Bad Person, but I’m still absolutely howling at the discomfiture of Pharma faced with the FDA’s ‘Bad Ad Program.’
As reported in Advertising Age by Rich Thomaselli: “’You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage.’”
One can only hope.
The FDA’s new program asks doctors to report any ads that omit or downplay the risk, overstate the effectiveness, or promote off-label use, of any drug. They can do so anonymously, which of course opens things up to everyone—the average pissed-off consumer who’s fed up with his kids watching sleazy primetime Viagra and Cialis commercials; angry parents who have watched a child suffering from what they believe to be side-effects from the heavily-promoted Gardasil vaccine; or any number of people who were convinced by sophisticated ads that they were suffering from ‘social anxiety disorder’ or ‘overactive bladder disorder’ and then found themselves hooked on crappy meds.
Truthfully, all pharmaceutical ads are bad ads. They market never previously heard-of conditions or hype others to the point that you’re certain you must have whatever it is. They recite side-effects, as required by law, only while playing happy, hopeful music and showing scenes of relief, joy, hope, love and Hallmark-style family life—with never a mention of the estimated 270 Americans who, according to journalist Melody Petersen, die every day from prescription medicines used as prescribed.
It’s curious that we ban ads for cigarettes but allow ads for medications. ‘DTC’—direct to consumer—refers only to pharma advertising, because for no other business do advertisers need to score an end run around a gatekeeper. After all, shouldn’t it be your doctor saying, “oh, you’re occasionally incontinent? Hey, do some Kegels and knock it off on the coffee—and if things get really bad, there’s a drug I can prescribe,” rather than the patient saying, “Doctor, I suffer from a Overactive Bladder Disorder and I can cure it with this excellent drug I heard about during MacGyver—give it to me, now!”?
Heck, no. There’s no money in that.
And it’s not just the annual $5 billion in DTC advertising that’s a concern, although there are now terrifying rumblings about ‘product placement’ ads (how do you think they’ll get in those mandated risk disclosures? Don’t worry; they’ll think of something). Pharma markets deceptively to doctors, too.
There was the scandal about a very convincing fake medical journal designed to fool doctors into prescribing Vioxx (read about it here).
Then there was that study that found that much of the drug trial information that’s written up in medical journals is skewed and often ghost-written by Pharma (read about it here).
There was even a UM study that found that “where a potential conflict (of interest, due to pharma funding or financial interest) existed, randomized trials were more likely to link patient survival to a particular treatment.” Read about that here.
And I’ve recently been dipping into Melody Petersen’s fascinating book, Our Daily Meds. Read it and weep. (No, really. I wept from sheer frustration with the perversion of pharma's power to heal, and you will, too.)
So should we call the FDA about the Gardasil campaign? Eminently watchable girl-power ads with smart girls and slightly emo skateboarders, all taking charge of their health and vowing to be one less? Is that bad advertising?
Well, I’m not necessarily going to take issue with calling it a cancer vaccine, despite the inevitable inference that it will put an end to cervical cancer—which it certainly won’t—and despite the risk of replacement disease, alteration of natural immunity, etc. that could lead to new causes of cervical cancer. Accepting surrogate endpoints isn’t unreasonable, although so far Gardasil isn’t exactly setting the world on fire results-wise.
But I can certainly take issue with Merck’s overstatement of the case for Gardasil. Heck, even the Journal of the American Medical Association did that. Drs. Sheila and David Rothman wrote in JAMA that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”
Here's my Truth in Advertising version of Gardasil ads from last year.
Anyway, if you’re, ahem, a doctor, and want to report a Bad Ad, here’s where to do it: email badad@fda.gov or call 877-RX-DDMAC. Be prepared to state your case; you’ll need to provide very specific and concise information about how the ad violates the law if you want to be taken seriously.
Now whether any Pharma ads at all should be legal—well, that’s another matter. You need to have a chat with your legislative representatives about that.
© 2010 http://www.gardasilhpv.com/ Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
As reported in Advertising Age by Rich Thomaselli: “’You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage.’”
One can only hope.
The FDA’s new program asks doctors to report any ads that omit or downplay the risk, overstate the effectiveness, or promote off-label use, of any drug. They can do so anonymously, which of course opens things up to everyone—the average pissed-off consumer who’s fed up with his kids watching sleazy primetime Viagra and Cialis commercials; angry parents who have watched a child suffering from what they believe to be side-effects from the heavily-promoted Gardasil vaccine; or any number of people who were convinced by sophisticated ads that they were suffering from ‘social anxiety disorder’ or ‘overactive bladder disorder’ and then found themselves hooked on crappy meds.
Truthfully, all pharmaceutical ads are bad ads. They market never previously heard-of conditions or hype others to the point that you’re certain you must have whatever it is. They recite side-effects, as required by law, only while playing happy, hopeful music and showing scenes of relief, joy, hope, love and Hallmark-style family life—with never a mention of the estimated 270 Americans who, according to journalist Melody Petersen, die every day from prescription medicines used as prescribed.
It’s curious that we ban ads for cigarettes but allow ads for medications. ‘DTC’—direct to consumer—refers only to pharma advertising, because for no other business do advertisers need to score an end run around a gatekeeper. After all, shouldn’t it be your doctor saying, “oh, you’re occasionally incontinent? Hey, do some Kegels and knock it off on the coffee—and if things get really bad, there’s a drug I can prescribe,” rather than the patient saying, “Doctor, I suffer from a Overactive Bladder Disorder and I can cure it with this excellent drug I heard about during MacGyver—give it to me, now!”?
Heck, no. There’s no money in that.
And it’s not just the annual $5 billion in DTC advertising that’s a concern, although there are now terrifying rumblings about ‘product placement’ ads (how do you think they’ll get in those mandated risk disclosures? Don’t worry; they’ll think of something). Pharma markets deceptively to doctors, too.
There was the scandal about a very convincing fake medical journal designed to fool doctors into prescribing Vioxx (read about it here).
Then there was that study that found that much of the drug trial information that’s written up in medical journals is skewed and often ghost-written by Pharma (read about it here).
There was even a UM study that found that “where a potential conflict (of interest, due to pharma funding or financial interest) existed, randomized trials were more likely to link patient survival to a particular treatment.” Read about that here.
And I’ve recently been dipping into Melody Petersen’s fascinating book, Our Daily Meds. Read it and weep. (No, really. I wept from sheer frustration with the perversion of pharma's power to heal, and you will, too.)
So should we call the FDA about the Gardasil campaign? Eminently watchable girl-power ads with smart girls and slightly emo skateboarders, all taking charge of their health and vowing to be one less? Is that bad advertising?
Well, I’m not necessarily going to take issue with calling it a cancer vaccine, despite the inevitable inference that it will put an end to cervical cancer—which it certainly won’t—and despite the risk of replacement disease, alteration of natural immunity, etc. that could lead to new causes of cervical cancer. Accepting surrogate endpoints isn’t unreasonable, although so far Gardasil isn’t exactly setting the world on fire results-wise.
But I can certainly take issue with Merck’s overstatement of the case for Gardasil. Heck, even the Journal of the American Medical Association did that. Drs. Sheila and David Rothman wrote in JAMA that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”
Here's my Truth in Advertising version of Gardasil ads from last year.
Anyway, if you’re, ahem, a doctor, and want to report a Bad Ad, here’s where to do it: email badad@fda.gov or call 877-RX-DDMAC. Be prepared to state your case; you’ll need to provide very specific and concise information about how the ad violates the law if you want to be taken seriously.
Now whether any Pharma ads at all should be legal—well, that’s another matter. You need to have a chat with your legislative representatives about that.
© 2010 http://www.gardasilhpv.com/ Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Wednesday, April 21, 2010
Gardasil and aluminum vaccine adjuvants: Researchers find neurological damage from aluminum adjuvants in two separate studies.
Science is a laborious process; two steps forward and one step back. Quicksilver minds formulate a hypothesis and painstakingly set out to prove it, and then other researchers argue, test, counter, and prove or disprove the results. Science is only ever what we know so far.
So when I read a study showing that an aluminum adjuvant, used in various vaccines including Gardasil, DTaP, Tdap, hepatitis A and B, and anthrax, had caused serious neurological problems in lab mice, I relaxed. I confidently assumed that I’d find studies and comments utterly refuting the work. Probably the FDA or CDC would have something reassuring to say about it.
Nothing.
OK, then. I contacted one of the study’s authors, Dr Chris Shaw, a research scientist at the University of British Columbia in Vancouver. He and his colleagues had, after all, set out to look at Gulf War Syndrome and the more than doubled rate of ALS in serving military personnel, not debunk vaccines.
Had he disproved his own study? Not at all. In fact, a second study had confirmed the first.
“We did do a second study with more animals that largely confirmed the first, including findings of altered memory functions,” he wrote back. “Additional histology from the first study also clearly showed the presence of aluminum in motor neurons in the spinal cord along with the expression of a protein associated with Alzheimer's disease.
“There is little doubt in the scientific literature that aluminum is toxic to cells, including human cells of all types (check the recent Keele conference on aluminum for more details). What the industry and most doctors argue is that the amount/shot is small. This is true, but what is not accounted for is the total body burden that kids today receive over their formative years. I'm close to your age and had maybe 10 shots before I was 20. The recommended number now is something over 40 before age 16.
“The second argument that aluminum is harmless is that as a common element we all eat milligrams of it daily. This is also true, but you should check out the papers of Dr. J. Walton of Australia who has clearly demonstrated Alzheimer's-like cognitive decline in older rats given aluminum in their water. In addition, vaccines present the aluminum in a very different way from the digestive system in that the injected aluminum goes into both the circulatory and lymphatic systems.”
When the first study was published, Shaw was quoted as saying he was “creeped out” by the unexpected results. Is he still creeped out?
Yes—“mostly by the lack of interest in most of the medical community….As for the various regulatory agencies: none commented on the results of our study. DOD declined to comment when asked.”
The FDA’s official position on aluminum adjuvants—adjuvants are used to increase the body’s immune response to vaccines—is that:
“Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. Of note, the most common source of exposure to aluminum is from eating food or drinking water.”—FDA website.
Depends on your definition of a demonstrated safety profile. Aluminum used as an adjuvant is certainly known, albeit rarely, to cause macrophagic myofasciitis in genetically susceptible individuals. The symptoms of macrophagic myofasciitis, a muscle disease first identified in 1993, include joint and muscle pain, fever, weakness, fatigue, and muscle tenderness. Although these symptoms are commonly found in girls and women who may be suffering from an adverse reaction to Merck’s HPV vaccine Gardasil, it’s unknown how many have undergone a muscle biopsy to test for macrophagic myofasciitis.
What Dr Shaw and Dr Michael Petrik’s second study found was that mice injected with one equivalent-to-human dose of aluminum adjuvant, and then a second dose two weeks later, “showed significantly increased apoptosis of motor neurons and increases in reactive astrocytes and microglia proliferation within the spinal cord and cortex.
“Morin stain detected the presence of aluminum in the cytoplasm of motor neurons with some neurons also testing positive for the presence of hyper-phosphorylated tau protein, a pathological hallmark of various neurological diseases, including Alzheimer’s disease and frontotemporal dementia. A second series of experiments was conducted on mice injected with six doses of aluminum hydroxide. Behavioural analyses in these mice revealed significant impairments in a number of motor functions as well as diminished spatial memory capacity. The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant suggest that greater scrutiny by the scientific community is warranted.” (My emphasis.)
In the interests of brevity, that’s from the abstract. I’d recommend reading the entire paper as published in the Nov. 2009 Journal of Inorganic Biochemistry.
But I have to include this (references deleted for ease of reading) from the body of the article.
“In spite of the long history of widespread use, the physicochemical interactions between aluminum compounds and antigens are relatively poorly understood and their underlying mechanisms remain relatively unstudied. It also seems that there have been no rigorous animal studies of potential aluminum adjuvant toxicity. The absence of such studies is peculiar given the well known observation that aluminum in general can be neurotoxic under a number of conditions and adjuvants in particular have previously been implicated in neurological disease.”
Peculiar? That’s an understatement.
I forwarded the article to a number of scientist buddies for comment and possible dismemberment. I hung onto this post for months, innocently awaiting responses, and got literally none. Like Dr Shaw, I was surprised and disconcerted by the lack of apparent interest. I’ve seen polio; I’m not anti-vaccine—but I’m all for ensuring that vaccines are as safe as they possibly can be. These are our children.
Since when has science been about accepting decades-old dogma without question? And why is it scientifically OK to use an aluminum adjuvant in the placebo group of a vaccine trial, as Merck did, thus potentially masking adjuvant-related adverse reactions?
I don’t expect the FDA to be interested in my ideas. But I do expect it—and pay its employees—to be interested in the safety of my children. So when a reputable, qualified team of scientists in a reputable research facility raises a legitimate safety question, I’d anticipate that the FDA would respond with unbiased concern and curiosity rather than silence.
Now I’m creeped out.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
So when I read a study showing that an aluminum adjuvant, used in various vaccines including Gardasil, DTaP, Tdap, hepatitis A and B, and anthrax, had caused serious neurological problems in lab mice, I relaxed. I confidently assumed that I’d find studies and comments utterly refuting the work. Probably the FDA or CDC would have something reassuring to say about it.
Nothing.
OK, then. I contacted one of the study’s authors, Dr Chris Shaw, a research scientist at the University of British Columbia in Vancouver. He and his colleagues had, after all, set out to look at Gulf War Syndrome and the more than doubled rate of ALS in serving military personnel, not debunk vaccines.
Had he disproved his own study? Not at all. In fact, a second study had confirmed the first.
“We did do a second study with more animals that largely confirmed the first, including findings of altered memory functions,” he wrote back. “Additional histology from the first study also clearly showed the presence of aluminum in motor neurons in the spinal cord along with the expression of a protein associated with Alzheimer's disease.
“There is little doubt in the scientific literature that aluminum is toxic to cells, including human cells of all types (check the recent Keele conference on aluminum for more details). What the industry and most doctors argue is that the amount/shot is small. This is true, but what is not accounted for is the total body burden that kids today receive over their formative years. I'm close to your age and had maybe 10 shots before I was 20. The recommended number now is something over 40 before age 16.
“The second argument that aluminum is harmless is that as a common element we all eat milligrams of it daily. This is also true, but you should check out the papers of Dr. J. Walton of Australia who has clearly demonstrated Alzheimer's-like cognitive decline in older rats given aluminum in their water. In addition, vaccines present the aluminum in a very different way from the digestive system in that the injected aluminum goes into both the circulatory and lymphatic systems.”
When the first study was published, Shaw was quoted as saying he was “creeped out” by the unexpected results. Is he still creeped out?
Yes—“mostly by the lack of interest in most of the medical community….As for the various regulatory agencies: none commented on the results of our study. DOD declined to comment when asked.”
The FDA’s official position on aluminum adjuvants—adjuvants are used to increase the body’s immune response to vaccines—is that:
“Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. Of note, the most common source of exposure to aluminum is from eating food or drinking water.”—FDA website.
Depends on your definition of a demonstrated safety profile. Aluminum used as an adjuvant is certainly known, albeit rarely, to cause macrophagic myofasciitis in genetically susceptible individuals. The symptoms of macrophagic myofasciitis, a muscle disease first identified in 1993, include joint and muscle pain, fever, weakness, fatigue, and muscle tenderness. Although these symptoms are commonly found in girls and women who may be suffering from an adverse reaction to Merck’s HPV vaccine Gardasil, it’s unknown how many have undergone a muscle biopsy to test for macrophagic myofasciitis.
What Dr Shaw and Dr Michael Petrik’s second study found was that mice injected with one equivalent-to-human dose of aluminum adjuvant, and then a second dose two weeks later, “showed significantly increased apoptosis of motor neurons and increases in reactive astrocytes and microglia proliferation within the spinal cord and cortex.
“Morin stain detected the presence of aluminum in the cytoplasm of motor neurons with some neurons also testing positive for the presence of hyper-phosphorylated tau protein, a pathological hallmark of various neurological diseases, including Alzheimer’s disease and frontotemporal dementia. A second series of experiments was conducted on mice injected with six doses of aluminum hydroxide. Behavioural analyses in these mice revealed significant impairments in a number of motor functions as well as diminished spatial memory capacity. The demonstrated neurotoxicity of aluminum hydroxide and its relative ubiquity as an adjuvant suggest that greater scrutiny by the scientific community is warranted.” (My emphasis.)
In the interests of brevity, that’s from the abstract. I’d recommend reading the entire paper as published in the Nov. 2009 Journal of Inorganic Biochemistry.
But I have to include this (references deleted for ease of reading) from the body of the article.
“In spite of the long history of widespread use, the physicochemical interactions between aluminum compounds and antigens are relatively poorly understood and their underlying mechanisms remain relatively unstudied. It also seems that there have been no rigorous animal studies of potential aluminum adjuvant toxicity. The absence of such studies is peculiar given the well known observation that aluminum in general can be neurotoxic under a number of conditions and adjuvants in particular have previously been implicated in neurological disease.”
Peculiar? That’s an understatement.
I forwarded the article to a number of scientist buddies for comment and possible dismemberment. I hung onto this post for months, innocently awaiting responses, and got literally none. Like Dr Shaw, I was surprised and disconcerted by the lack of apparent interest. I’ve seen polio; I’m not anti-vaccine—but I’m all for ensuring that vaccines are as safe as they possibly can be. These are our children.
Since when has science been about accepting decades-old dogma without question? And why is it scientifically OK to use an aluminum adjuvant in the placebo group of a vaccine trial, as Merck did, thus potentially masking adjuvant-related adverse reactions?
I don’t expect the FDA to be interested in my ideas. But I do expect it—and pay its employees—to be interested in the safety of my children. So when a reputable, qualified team of scientists in a reputable research facility raises a legitimate safety question, I’d anticipate that the FDA would respond with unbiased concern and curiosity rather than silence.
Now I’m creeped out.
© 2010 www.gardasilhpv.com
Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.
Friday, April 16, 2010
Gardasil and seizures to be considered by Vaccine Court
Last year the FDA mandated a revised label for Gardasil, warning health care providers about the continuing reports of syncope in those who’ve received the HPV vaccine, including “jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.”
However, stories about post- Gardasil epilepsy, continuing seizures and convulsions that are certainly not merely “syncope” continue to pour in—and on Wednesday the Ronan Law Firm filed a petition “in the United States Court of Federal Claims seeking damages for injuries suffered by 16 year old Alexis Wolf after she received the human papillomavirus vaccine, Gardasil. The case seeks recovery under the terms of the National Vaccine Injury Compensation Program.”
Wolf, who is diabetic, received all three Gardasil shots although she had already begun exhibiting some perplexing behavioral issues by the time she got the third shot. Eventually a psychiatrist realized that she was in fact suffering seizures that apparently cannot be controlled by medication. According to information posted by her parents, the former honor roll student now tests at a fourth grade level and is in constant pain.
Yesterday I posed a question about Merck's HPV vaccine Gardasil, seizures and mitochondrial disease here .
It will be interesting to see how the federal vaccine court, which in 2008 awarded damages to a child whose undiagnosed mitochondrial disease was aggravated by multiple vaccines, rules on this new case.
Meanwhile, best wishes to Ms. Wolf and her family.
© 2010 http://www.gardasilhpv.com/.Permission is freely given to reproduce the first two paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at gardasilhpv@gmail.com.
However, stories about post- Gardasil epilepsy, continuing seizures and convulsions that are certainly not merely “syncope” continue to pour in—and on Wednesday the Ronan Law Firm filed a petition “in the United States Court of Federal Claims seeking damages for injuries suffered by 16 year old Alexis Wolf after she received the human papillomavirus vaccine, Gardasil. The case seeks recovery under the terms of the National Vaccine Injury Compensation Program.”
Wolf, who is diabetic, received all three Gardasil shots although she had already begun exhibiting some perplexing behavioral issues by the time she got the third shot. Eventually a psychiatrist realized that she was in fact suffering seizures that apparently cannot be controlled by medication. According to information posted by her parents, the former honor roll student now tests at a fourth grade level and is in constant pain.
Yesterday I posed a question about Merck's HPV vaccine Gardasil, seizures and mitochondrial disease here .
It will be interesting to see how the federal vaccine court, which in 2008 awarded damages to a child whose undiagnosed mitochondrial disease was aggravated by multiple vaccines, rules on this new case.
Meanwhile, best wishes to Ms. Wolf and her family.
© 2010 http://www.gardasilhpv.com/.Permission is freely given to reproduce the first two paragraphs of this article, along with a link back to this site and the entirety of the article. For other uses, please contact Kristin at gardasilhpv@gmail.com.
Thursday, February 25, 2010
Merck funding and the push to give Gardasil without parents’ knowledge or consent
Well, color me naïve. Last week I wrote here about two ill-advised bills currently attempting to make it legal for clinics and school nurses to give children HPV shots (Merck’s Gardasil is the brand most commonly used in the US)—regardless of age, and without their parents knowing a thing about it.
"Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck,” I wrote, “I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching.”
Now a regular reader has written to let me know that Senator Liz Krueger is in fact a member of Women in Government, a group that was heavily criticized for attempting to make vaccination with Gardasil mandatory for public school attendance after receiving substantial funding from Merck.
OK, sometimes I’m a real innocent.
"Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck,” I wrote, “I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching.”
Now a regular reader has written to let me know that Senator Liz Krueger is in fact a member of Women in Government, a group that was heavily criticized for attempting to make vaccination with Gardasil mandatory for public school attendance after receiving substantial funding from Merck.
OK, sometimes I’m a real innocent.
Thursday, February 18, 2010
Children to be given Gardasil or Cervarix without parents’ knowledge or consent?
Imagine. You brush up against your daughter and she winces; you pull up her sleeve and see the telltale needle mark. She’s what, perhaps 12 years old.
It was Gardasil, not heroin, duh, she says. The nurse said it was safe and now I will never get cervical cancer. Don’t you want me to stay healthy, Mom?
Well, yes. And so, because you know that she has a strong family history of autoimmune disease on both sides, you’ve deliberately chosen to protect her health by avoiding getting her extra shots. Particularly Gardasil, because it’s a novel type of genetically engineered vaccine, as yet unproven, and of questionable value. You’re cautious because it has anecdotally been associated with autoimmune diseases—which are triggered in susceptible individuals by environmental factors—and your doctor has advised you, dammit, to be cautious with shots.
But now your informed decision has been overridden by a complete stranger.
Ridiculous?
If the scenario of a minor child—as young as nine—being given a shot without a parent’s knowledge or consent seems absurd, think again. New York Senate bill S4779, sponsored by Senator Liz Krueger and co-sponsored by Senators Adams and Parker, provided for exactly that. And although S4779 has been held in the Senate Codes Committee for improvement and clarification of the bill's language, Ms. Krueger is reportedly determined to get it through at some point. Meanwhile, Assemblywoman Amy Paulin has sponsored New York Assembly bill A06702, which is almost identical apart from an attempt to make vaccination with Gardasil mandatory for school attendance.
The bills seek to ensure “that a health care practitioner may provide medical care related to the prevention of a sexually transmissible disease, including administering vaccines, to a person under age eighteen without the consent or knowledge of his or her parents or guardians, provided such person has capacity to consent to the care, without regard to the person's age, and the person consents. The section provides further that any release of patient information regarding vaccines provided under this section shall be consistent with sections 17 and 18 of the public health law.”
Wonderful. Not only could a nurse shoot up my kid with Gardasil or Cervarix even if I’ve specifically decided against it, I couldn’t find out for sure what those needle marks are. I’d have no clue as to why my child might have started convulsing, as did two girls in Spain right after getting their shots.
The whys and wherefores
Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck, I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching. Merck has done a fantastic job of persuading the public, including (apparently) some legislators, that if our kids don’t get the three Gardasil shots at a total cost of around $400 per child, they’re gonna get cervical cancer. Why bother to research the real facts?
Merck, of course, has notoriously been highly unscrupulous about its sales jobs—from concocting an entire fake medical journal and deliberately discrediting doctors and researchers who questioned Vioxx to paying off professional medical associations (PMAs) to promote Gardasil to other health professionals, without any appropriate transparency and discussion of risks and benefits. Not to mention its participation in the skewing of reporting drug trials endemic in professional journals.
The company is not going to spend a whole lot of effort on educating anyone about the full pros and cons of Gardasil and the truth about HPV. Particularly when its Gardasil sales have just plummeted by almost 80 percent in Australia, where a massive HPV vaccination campaign has ended.
Nor can we rely on doctors to educate themselves and us. In the context of Gardasil, Newsweek even quoted Susan Wood, former head of the FDA’s Office of Women’s Health, as believing that there was no relationship between a healthy diet and a strong immune system that could fight off HPV on its own and leave a natural immunity in its wake—totally contrary to solid scientific evidence.
And so we have legislators falling for the quick fix. Kids are having sex, their theory goes, and indulging in risky behavior. They already come to us to get birth control and treat STDs, so let’s PREVENT the STDs with a very expensive shot that must be safe because the government says so (Vioxx, anyone? BPA? Tambocor? Thalidomide?). It must be effective because Merck says so. Parents, of course, are just naïve, uncaring, and/or prudish and should have no say in the matter.
Never mind that kids who are already having sex have a heightened risk of developing a high-grade cervical abnormality if they are infected with vaccine-type HPV when they get Gardasil—particularly if they smoke.
The capacity to consent
But wait. The target kids have to have the “capacity to consent,” right? They can make decisions for themselves, especially if they’re already having sex, a supposedly adult activity. Gardasil is recommended for kids as young as nine, and kids as young as nine have been known to have sex ‘willingly.’
The capacity to consent implies the ability to understand and weigh all the pros and cons of Gardasil. Frankly, I’ve been giving my DOCTOR info that she, as an overworked professional, didn’t have previously. And yet Ms. Krueger and friends think that a nine year old—hell, a sixteen year old—can sit there and figure it all out before making an informed decision?
I’d think a lot better of Ms. Krueger if she initiated healthier foods in schools. Or campaigns that educated kids about the behaviors that cause persistent HPV infections and, potentially, cancers. I’d be good with efforts to teach parents about Gardasil, honestly cataloging the risks and benefits. I’m not necessarily against Gardasil for the right, most at-risk population as long as their family history is taken into consideration.
But I am totally against usurping parents’ rights, making uninformed decisions, and encouraging kids to make uninformed decisions. Especially when there’s a financial motive on the part of clinics and drug companies.
That’s what cigarette companies do. Is Senator Krueger the new face of the Marlboro Man?
Here’s the straight talk for your kids, just in case legislators nationwide are daft enough to jump on the Krueger bandwagon. What you need to know about Gardasil
It was Gardasil, not heroin, duh, she says. The nurse said it was safe and now I will never get cervical cancer. Don’t you want me to stay healthy, Mom?
Well, yes. And so, because you know that she has a strong family history of autoimmune disease on both sides, you’ve deliberately chosen to protect her health by avoiding getting her extra shots. Particularly Gardasil, because it’s a novel type of genetically engineered vaccine, as yet unproven, and of questionable value. You’re cautious because it has anecdotally been associated with autoimmune diseases—which are triggered in susceptible individuals by environmental factors—and your doctor has advised you, dammit, to be cautious with shots.
But now your informed decision has been overridden by a complete stranger.
Ridiculous?
If the scenario of a minor child—as young as nine—being given a shot without a parent’s knowledge or consent seems absurd, think again. New York Senate bill S4779, sponsored by Senator Liz Krueger and co-sponsored by Senators Adams and Parker, provided for exactly that. And although S4779 has been held in the Senate Codes Committee for improvement and clarification of the bill's language, Ms. Krueger is reportedly determined to get it through at some point. Meanwhile, Assemblywoman Amy Paulin has sponsored New York Assembly bill A06702, which is almost identical apart from an attempt to make vaccination with Gardasil mandatory for school attendance.
The bills seek to ensure “that a health care practitioner may provide medical care related to the prevention of a sexually transmissible disease, including administering vaccines, to a person under age eighteen without the consent or knowledge of his or her parents or guardians, provided such person has capacity to consent to the care, without regard to the person's age, and the person consents. The section provides further that any release of patient information regarding vaccines provided under this section shall be consistent with sections 17 and 18 of the public health law.”
Wonderful. Not only could a nurse shoot up my kid with Gardasil or Cervarix even if I’ve specifically decided against it, I couldn’t find out for sure what those needle marks are. I’d have no clue as to why my child might have started convulsing, as did two girls in Spain right after getting their shots.
The whys and wherefores
Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck, I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching. Merck has done a fantastic job of persuading the public, including (apparently) some legislators, that if our kids don’t get the three Gardasil shots at a total cost of around $400 per child, they’re gonna get cervical cancer. Why bother to research the real facts?
Merck, of course, has notoriously been highly unscrupulous about its sales jobs—from concocting an entire fake medical journal and deliberately discrediting doctors and researchers who questioned Vioxx to paying off professional medical associations (PMAs) to promote Gardasil to other health professionals, without any appropriate transparency and discussion of risks and benefits. Not to mention its participation in the skewing of reporting drug trials endemic in professional journals.
The company is not going to spend a whole lot of effort on educating anyone about the full pros and cons of Gardasil and the truth about HPV. Particularly when its Gardasil sales have just plummeted by almost 80 percent in Australia, where a massive HPV vaccination campaign has ended.
Nor can we rely on doctors to educate themselves and us. In the context of Gardasil, Newsweek even quoted Susan Wood, former head of the FDA’s Office of Women’s Health, as believing that there was no relationship between a healthy diet and a strong immune system that could fight off HPV on its own and leave a natural immunity in its wake—totally contrary to solid scientific evidence.
And so we have legislators falling for the quick fix. Kids are having sex, their theory goes, and indulging in risky behavior. They already come to us to get birth control and treat STDs, so let’s PREVENT the STDs with a very expensive shot that must be safe because the government says so (Vioxx, anyone? BPA? Tambocor? Thalidomide?). It must be effective because Merck says so. Parents, of course, are just naïve, uncaring, and/or prudish and should have no say in the matter.
Never mind that kids who are already having sex have a heightened risk of developing a high-grade cervical abnormality if they are infected with vaccine-type HPV when they get Gardasil—particularly if they smoke.
The capacity to consent
But wait. The target kids have to have the “capacity to consent,” right? They can make decisions for themselves, especially if they’re already having sex, a supposedly adult activity. Gardasil is recommended for kids as young as nine, and kids as young as nine have been known to have sex ‘willingly.’
The capacity to consent implies the ability to understand and weigh all the pros and cons of Gardasil. Frankly, I’ve been giving my DOCTOR info that she, as an overworked professional, didn’t have previously. And yet Ms. Krueger and friends think that a nine year old—hell, a sixteen year old—can sit there and figure it all out before making an informed decision?
I’d think a lot better of Ms. Krueger if she initiated healthier foods in schools. Or campaigns that educated kids about the behaviors that cause persistent HPV infections and, potentially, cancers. I’d be good with efforts to teach parents about Gardasil, honestly cataloging the risks and benefits. I’m not necessarily against Gardasil for the right, most at-risk population as long as their family history is taken into consideration.
But I am totally against usurping parents’ rights, making uninformed decisions, and encouraging kids to make uninformed decisions. Especially when there’s a financial motive on the part of clinics and drug companies.
That’s what cigarette companies do. Is Senator Krueger the new face of the Marlboro Man?
Here’s the straight talk for your kids, just in case legislators nationwide are daft enough to jump on the Krueger bandwagon. What you need to know about Gardasil
Friday, January 15, 2010
Merck looks to expand $400 Gardasil use while scientists say a $2 test could prevent 100,000 deaths from cervical cancer
Maybe it’s just me. But I found it extraordinarily offensive that on the same day that scientists in Britain reported that 100,000 deaths from cervical cancer could be prevented annually by the use of a $2 test overseas, reports surfaced that Merck is once again trying to get approval for Gardasil (cost: $360 per person, plus whatever health care providers charge for administering it) to be used for women aged 27-45.
The difference is, of course, that expensive Gardasil will be used in the US, where it is least needed. Although at least 80 percent of women here will be infected by the HPV virus, 95 percent of those infections will be shrugged off by healthy immune systems, leaving in their wake a natural immunity to further infection. Of the small percentage of cases that become persistent, many could be avoided by eating a healthy diet with fruits and vegetables, quitting smoking, getting enough sleep, limiting sexual partners, etc. And most (granted, not all) persistent HPV infections that do turn to cancer can be caught early by regular screening.
Still, an incredibly effective marketing scheme that fails utterly to accurately inform women about the pros and cons of the vaccine has convinced women that unless they pony up big bucks they’re going to get cervical cancer.
Now Merck, dismayed by flagging sales and by clear evidence that Gardasil isn’t cost-effective for the potentially lucrative male market and its recommendation only as a wart-preventer and not as a cancer preventative for boys, is once again going after the older women market. It will be interesting to see whether they have found a way around earlier evidence that Gardasil may actually cause existing HPV infections to become cancerous.
Meanwhile, in developing countries, where women often aren’t able to get regular life-saving Pap smears and equally often have depleted immune systems due to inadequate diet—countries where Gardasil would actually make sense—a simple, dirt-cheap test could really, truly save lives. It can be used in rural areas without sophisticated equipment and labs; a nurse, midwife, or OB/GYN simply swipes the patient's cervix with acetic acid (vinegar) and then looks at the tissue. If lesions are present, the tissue turns white.
The only obstacles? Raising awareness, and getting enough money and qualified people to do the $2 tests and follow-up. Without, of course, a fraction of the budget that Merck has used to sell the largely unnecessary Gardasil vaccine.
So once again, I’m telling Blue Cross/Blue Shield: thanks for offering my girls the vaccine, but please send the $800 to an appropriate charity that offers VIA screenings to women in developing countries instead. Hey, that’s 400 potentially life-saving tests. Doesn’t that sound more cost-effective than inoculating two very low-risk girls?
The difference is, of course, that expensive Gardasil will be used in the US, where it is least needed. Although at least 80 percent of women here will be infected by the HPV virus, 95 percent of those infections will be shrugged off by healthy immune systems, leaving in their wake a natural immunity to further infection. Of the small percentage of cases that become persistent, many could be avoided by eating a healthy diet with fruits and vegetables, quitting smoking, getting enough sleep, limiting sexual partners, etc. And most (granted, not all) persistent HPV infections that do turn to cancer can be caught early by regular screening.
Still, an incredibly effective marketing scheme that fails utterly to accurately inform women about the pros and cons of the vaccine has convinced women that unless they pony up big bucks they’re going to get cervical cancer.
Now Merck, dismayed by flagging sales and by clear evidence that Gardasil isn’t cost-effective for the potentially lucrative male market and its recommendation only as a wart-preventer and not as a cancer preventative for boys, is once again going after the older women market. It will be interesting to see whether they have found a way around earlier evidence that Gardasil may actually cause existing HPV infections to become cancerous.
Meanwhile, in developing countries, where women often aren’t able to get regular life-saving Pap smears and equally often have depleted immune systems due to inadequate diet—countries where Gardasil would actually make sense—a simple, dirt-cheap test could really, truly save lives. It can be used in rural areas without sophisticated equipment and labs; a nurse, midwife, or OB/GYN simply swipes the patient's cervix with acetic acid (vinegar) and then looks at the tissue. If lesions are present, the tissue turns white.
The only obstacles? Raising awareness, and getting enough money and qualified people to do the $2 tests and follow-up. Without, of course, a fraction of the budget that Merck has used to sell the largely unnecessary Gardasil vaccine.
So once again, I’m telling Blue Cross/Blue Shield: thanks for offering my girls the vaccine, but please send the $800 to an appropriate charity that offers VIA screenings to women in developing countries instead. Hey, that’s 400 potentially life-saving tests. Doesn’t that sound more cost-effective than inoculating two very low-risk girls?
Wednesday, October 21, 2009
Gardasil Optional, Not Recommended, for Boys--Will You Pay for It?
It’s up to you now. The Advisory Committee on Immunization Practices voted almost unanimously to tell doctors that they’re free to give boys the Gardasil vaccine as a way of avoiding future bouts with genital warts—which affect about one percent of the population—but they’re not going to recommend it as a routine vaccination.
Nor do they plan to recommend it as an “anti-cancer” vaccine, which is the way it’s been sold to many millions of girls. Although the HPV virus can cause esophageal, anal, testicular, penile and perineal cancer in boys, such cancers are very rare, and even then a large percentage aren’t associated with the human papillomavirus. The only real advantage would be to protect future partners.
Merck, with billions on the line, had determined that the vaccine would be very cost-effective for boys by assuming that the vaccine would be 100 percent effective in preventing cancer and that the vaccine would cost $400 per child—at $360 for the cost of the shots alone, that doesn’t leave much to pay the cost of three visits to the doctor.
A Harvard study, however, went on the assumption that the vaccine would be 75 percent effective and cost $500 per child, and found that the cost of vaccinating boys would be spectacularly cost-ineffective.
The Advisory Committee apparently agreed with Harvard.
There is certainly no reason to assume that Gardasil will be 100 percent effective. Merck’s own study of more than 4,000 boys didn’t even find that, and Gardasil trials have shown the HPV vaccine to be just 17-45 percent effective in preventing cervical abnormalities in girls thus far. Gardasil has also been associated anecdotally with a number of rare, but serious, side effects, including autoimmune diseases and a form of ALS.
Meanwhile, it’s doubtful that many insurance companies will now pay for Gardasil for boys, although government programs may do so for those on Medicaid. Parents might prefer to be sure that their children understand the importance of getting annual exams as adults and of eating fruits and vegetables, avoiding smoking, being circumcised, getting sufficient sleep, and limiting the number of sexual partners—all factors that are known to substantially cut the risk of getting a persistent HPV infection.
So are you willing to fork over the cash yourself? Do you think Gardasil’s worth it?
Nor do they plan to recommend it as an “anti-cancer” vaccine, which is the way it’s been sold to many millions of girls. Although the HPV virus can cause esophageal, anal, testicular, penile and perineal cancer in boys, such cancers are very rare, and even then a large percentage aren’t associated with the human papillomavirus. The only real advantage would be to protect future partners.
Merck, with billions on the line, had determined that the vaccine would be very cost-effective for boys by assuming that the vaccine would be 100 percent effective in preventing cancer and that the vaccine would cost $400 per child—at $360 for the cost of the shots alone, that doesn’t leave much to pay the cost of three visits to the doctor.
A Harvard study, however, went on the assumption that the vaccine would be 75 percent effective and cost $500 per child, and found that the cost of vaccinating boys would be spectacularly cost-ineffective.
The Advisory Committee apparently agreed with Harvard.
There is certainly no reason to assume that Gardasil will be 100 percent effective. Merck’s own study of more than 4,000 boys didn’t even find that, and Gardasil trials have shown the HPV vaccine to be just 17-45 percent effective in preventing cervical abnormalities in girls thus far. Gardasil has also been associated anecdotally with a number of rare, but serious, side effects, including autoimmune diseases and a form of ALS.
Meanwhile, it’s doubtful that many insurance companies will now pay for Gardasil for boys, although government programs may do so for those on Medicaid. Parents might prefer to be sure that their children understand the importance of getting annual exams as adults and of eating fruits and vegetables, avoiding smoking, being circumcised, getting sufficient sleep, and limiting the number of sexual partners—all factors that are known to substantially cut the risk of getting a persistent HPV infection.
So are you willing to fork over the cash yourself? Do you think Gardasil’s worth it?
Saturday, October 10, 2009
Dr. Diane Harper Badly Misquoted on Gardasil and Cervarix
I’m not a regular reader of the Guardian’s “woo-medicine”-debunking columnist Ben Goldacre, and when I do read him I often disagree with him.
But he hit a home run with his latest Bad Science column.
He took apart a front page Sunday Express article that has already been widely disseminated around scare sites on the Internet. Of course, you can’t read it on the Sunday Express site anymore because it's been removed. Probably because Dr Diane Harper, who was quoted as saying that HPV vaccines are more dangerous than cervical cancer, is about to sue the pin-striped pants off the always-lurid Express. Or so I hope.
I’ve often felt sorry for Dr Harper. She seems like a forthright, intelligent scientist who removes herself from Merck’s marketing hysteria to make sensible cautionary comments about the Gardasil vaccine, which she has worked on and in general supports. But her comments are frequently taken out of context and paraded around the web as if she were an anti-vaccine crusader.
As someone who is wary of Gardasil to the point of thus far turning it down for my daughters, who have a family history of autoimmune disease; as someone who would like to see an awful lot of very serious questions about Gardasil taken very seriously and answered very seriously, it makes me LIVID. We need more people in the pharmaceutical industry to encourage scientists, physicians and the public to ask intelligent questions and not simply swallow the party line wholesale. So-called reporters like the notorious Express’s Lucy Johnston badly undermine the likelihood of that happening.
If I’ve understood Dr. Harper correctly—forgive me if I haven’t, Dr. Harper, and feel free to correct me—she thinks that HPV vaccines are in general a good thing but that Gardasil should have been introduced more slowly and cautiously; and that perhaps people with family histories of auto-immune disorders should be particularly cautious. She thinks—again, if I understand correctly—that Merck’s unprecedented intensive marketing campaign has oversold Gardasil; that the 3-shot series and its marketing might make women cavalier about still-essential annual exams; that we don’t know how long protection will last.
According to Goldacre, what she doesn’t think is what she was reported as saying in the Express’s article. That the cervical cancer vaccine 'may be riskier and more deadly than the cancer it is designed to prevent.' That the jab 'would do nothing to reduce the rates of cervical cancer in the UK.' Etc., etc., etc.
Goldacre simply contacted Harper directly when he read the article.
“I will explain Harper's position in her own words,” he writes. “They are unambiguous: ‘I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a 'controversial drug'. I did not 'hit out' – I was contacted by the press for facts. And this was not an exclusive interview.”
Harper did not "develop Cervarix" but she did work on some important trials of Gardasil and also Cervarix. "Gardasil is not a 'sister vaccine' as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.’
“She did not say that Cervarix was being overmarketed. ‘I did say that Merck was egregiously overmarketing Gardasil in the US – but Gardasil and Cervarix are not the same vaccines’…She also suspects from modelling data that for the specific and restricted group of women who are punctilious about attending every single one of their cervical cancer screening appointments, vaccination may have little impact on their risk of death from cancer; but even they will benefit from the reduction in reproductive problems caused by treating pre-cancerous changes in cervical cells.
‘I fully support the HPV vaccines," she says. "I believe that in general they are safe in most women. I told the Express all of this.’”
That was a lot of Goldacre’s column to reproduce. But I think it bears repeating as long as the Sunday Express article inevitably circulates and spawns more mis-information.
But he hit a home run with his latest Bad Science column.
He took apart a front page Sunday Express article that has already been widely disseminated around scare sites on the Internet. Of course, you can’t read it on the Sunday Express site anymore because it's been removed. Probably because Dr Diane Harper, who was quoted as saying that HPV vaccines are more dangerous than cervical cancer, is about to sue the pin-striped pants off the always-lurid Express. Or so I hope.
I’ve often felt sorry for Dr Harper. She seems like a forthright, intelligent scientist who removes herself from Merck’s marketing hysteria to make sensible cautionary comments about the Gardasil vaccine, which she has worked on and in general supports. But her comments are frequently taken out of context and paraded around the web as if she were an anti-vaccine crusader.
As someone who is wary of Gardasil to the point of thus far turning it down for my daughters, who have a family history of autoimmune disease; as someone who would like to see an awful lot of very serious questions about Gardasil taken very seriously and answered very seriously, it makes me LIVID. We need more people in the pharmaceutical industry to encourage scientists, physicians and the public to ask intelligent questions and not simply swallow the party line wholesale. So-called reporters like the notorious Express’s Lucy Johnston badly undermine the likelihood of that happening.
If I’ve understood Dr. Harper correctly—forgive me if I haven’t, Dr. Harper, and feel free to correct me—she thinks that HPV vaccines are in general a good thing but that Gardasil should have been introduced more slowly and cautiously; and that perhaps people with family histories of auto-immune disorders should be particularly cautious. She thinks—again, if I understand correctly—that Merck’s unprecedented intensive marketing campaign has oversold Gardasil; that the 3-shot series and its marketing might make women cavalier about still-essential annual exams; that we don’t know how long protection will last.
According to Goldacre, what she doesn’t think is what she was reported as saying in the Express’s article. That the cervical cancer vaccine 'may be riskier and more deadly than the cancer it is designed to prevent.' That the jab 'would do nothing to reduce the rates of cervical cancer in the UK.' Etc., etc., etc.
Goldacre simply contacted Harper directly when he read the article.
“I will explain Harper's position in her own words,” he writes. “They are unambiguous: ‘I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a 'controversial drug'. I did not 'hit out' – I was contacted by the press for facts. And this was not an exclusive interview.”
Harper did not "develop Cervarix" but she did work on some important trials of Gardasil and also Cervarix. "Gardasil is not a 'sister vaccine' as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.’
“She did not say that Cervarix was being overmarketed. ‘I did say that Merck was egregiously overmarketing Gardasil in the US – but Gardasil and Cervarix are not the same vaccines’…She also suspects from modelling data that for the specific and restricted group of women who are punctilious about attending every single one of their cervical cancer screening appointments, vaccination may have little impact on their risk of death from cancer; but even they will benefit from the reduction in reproductive problems caused by treating pre-cancerous changes in cervical cells.
‘I fully support the HPV vaccines," she says. "I believe that in general they are safe in most women. I told the Express all of this.’”
That was a lot of Goldacre’s column to reproduce. But I think it bears repeating as long as the Sunday Express article inevitably circulates and spawns more mis-information.
Tuesday, August 25, 2009
Gardasil — Exempt from Truth in Advertising Standards?
People who ask questions about Gardasil are invariably told that they’re scientific ignoramuses, endangering their children with their crazy paranoia. Last week, however, JAMA, the Journal of the American Medical Association, issued stinging critiques of the over-selling of the HPV vaccine and the potential skewing of any risk/benefits analysis. It was rare criticism from the medical profession.
The truth is, we have more legal protection from an under-powered blender than we do from a vaccine.
Gardasil could well be the best thing since the invention of SmartPhones. But it could also alter our life for the worse, permanently, or it could simply be a waste of time and money. Merck and the FDA are making highly educated guesses, but you’d never know that from the hype. As consumers, isn’t it time we started demanding a little respect and honesty? Don’t we deserve sufficient information to come to a reasonable decision?
Under the Federal Trade Commission Act, advertising must be truthful and fair, and it must not deceive. Advertisers must have evidence to back up their claims. An ad is considered deceptive if it either contains a statement or omits information that might well mislead consumers who are acting reasonably under the circumstances. It also must not omit information that is important to a consumer’s decision to use or buy the product.
With Gardasil’s unprecedented marketing, said Drs. Sheila and David Rothman in JAMA, “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”
Science can be defined as ‘what we know so far.’ Or as Dr. Charlotte Haug put it in her JAMA editorial about Gardasil, “medical knowledge is typically incomplete and ambiguous.” Often, what we think we know turns out to be wrong, or just the tip of the iceberg. It would be totally irrational to reject all medical science on the basis that we might find out something to the contrary later, but it is equally irrational to try to make a decision about a new treatment without being in possession of all the known facts, particularly when huge financial benefits to the vendor weigh in.
“GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases,” says Merck. “Be one less,” say the ads. The implication: if you don’t get Gardasil, you do get cervical cancer.
Here’s my Truth in Advertising version.
Gardasil targets the two strains of the HPV virus that currently cause 70 percent of cases of cervical cancer and two strains that cause genital warts. Your chance of dying from cervical cancer is extremely small if you have regular check-ups. HPV may also cause (even more rarely) cases of oral cancer, anal cancer, and penile cancer. We do not yet know whether Gardasil will be effective against these cancers and will not know for several decades, but the hypothesis seems likely to some degree.
You can reduce your small chance of developing HPV-related cancers dramatically by eating healthy foods, by not smoking, by limiting your sexual partners, and by undergoing regular screenings. 95 percent of cases of HPV are currently shrugged off by the body. You should consider your lifestyle honestly when making a risk/benefit analysis.
Gardasil may offer some further protection. After 3.6 years, the results from two randomized, placebo-controlled trials following 17,622 women who were vaccinated with Gardasil after showing no previous exposure to 14 HPV types and had normal Pap smears to begin with were:
· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significanceassociated with a high-risk type of HPV
· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion
· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion
· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Protection against genital warts appears to be extremely good.
We do not know whether replacement diseases will occur should non-vaccine strains of the virus (there are more than 100, and at least 15 are known to be oncogenic) fill the biological niche left by vaccine strains. We do not believe that this is likely but the vaccine Prevnar has shown that it can happen.
We do not know how Gardasil will affect natural immunity to the more than 100 strains of HPV.
We do not know how long immunity will last and whether single, or perhaps multiple, booster shots will be necessary. We do not know whether, should immunity to HPV-16 and HPV-18 wear off, older adults will be able to fight off the virus as well as younger adults.
Data from the passive VAERS system that is used to monitor vaccine adverse events, along with data from clinical trials, appears to indicate that Gardasil is well-tolerated by the vast majority of individuals. The FDA has determined a slightly greater risk of fainting and associated injury and of blood clots.
Anecdotal evidence and VAERS reports associate Gardasil with an increased risk of auto-immune disease and neurological problems, including rapid-onset ALS, arthritis, Graves Disease, paralysis, seizures, chronic headache, etc., predominantly in very active girls, but no causal link has been found at this time and incidence does not occur at a very significantly greater rate than in the general population. Incidence of auto-immune disease, which may be triggered in genetically pre-disposed individuals and more often in women by environmental factors, is generally rising. We do not know why. We do not know if a rapidly increasing lifetime burden of vaccine adjuvants plays some part, although high levels of aluminum have reportedly been found in spinal taps from some affected girls.
There was concern that initial studies of Gardasil showed a 44.6 percent increase in CIN 2/3 (the highest grade of pre-cancerous lesion) in a sub-group of individuals who had existing vaccine-type infections at time of vaccination. Further analysis showed that an unbalanced proportion of these subjects may have had enhanced risk factors such as a current smoking habit or a history of cervicovaginal infection or STD. Background evidence provided to the committee approving Gardasil concluded that, after balancing risk factors and sub-dividing sub-groups, vaccination could be said to reduce CIN2/3 by a modest 5.5 percent. Overall, a combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent in subjects who tested positive for vaccine-relevant HPV at the beginning of the study.
You may wish to get an HPV test and/or a pregnancy test prior to vaccination. You may wish discuss the advisability of vaccination with your doctor if you or your family has a history of autoimmune disorders.
You should not get Gardasil if you’re allergic to yeast or if you’re pregnant or planning to become pregnant soon.
You should report any and all potential adverse reactions to VAERS, being sure to include valid contact information, and not just all immediately post-vaccination allergic reactions, as the CDC’s handout implies.
The truth is, we have more legal protection from an under-powered blender than we do from a vaccine.
Gardasil could well be the best thing since the invention of SmartPhones. But it could also alter our life for the worse, permanently, or it could simply be a waste of time and money. Merck and the FDA are making highly educated guesses, but you’d never know that from the hype. As consumers, isn’t it time we started demanding a little respect and honesty? Don’t we deserve sufficient information to come to a reasonable decision?
Under the Federal Trade Commission Act, advertising must be truthful and fair, and it must not deceive. Advertisers must have evidence to back up their claims. An ad is considered deceptive if it either contains a statement or omits information that might well mislead consumers who are acting reasonably under the circumstances. It also must not omit information that is important to a consumer’s decision to use or buy the product.
With Gardasil’s unprecedented marketing, said Drs. Sheila and David Rothman in JAMA, “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”
Science can be defined as ‘what we know so far.’ Or as Dr. Charlotte Haug put it in her JAMA editorial about Gardasil, “medical knowledge is typically incomplete and ambiguous.” Often, what we think we know turns out to be wrong, or just the tip of the iceberg. It would be totally irrational to reject all medical science on the basis that we might find out something to the contrary later, but it is equally irrational to try to make a decision about a new treatment without being in possession of all the known facts, particularly when huge financial benefits to the vendor weigh in.
“GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases,” says Merck. “Be one less,” say the ads. The implication: if you don’t get Gardasil, you do get cervical cancer.
Here’s my Truth in Advertising version.
Gardasil targets the two strains of the HPV virus that currently cause 70 percent of cases of cervical cancer and two strains that cause genital warts. Your chance of dying from cervical cancer is extremely small if you have regular check-ups. HPV may also cause (even more rarely) cases of oral cancer, anal cancer, and penile cancer. We do not yet know whether Gardasil will be effective against these cancers and will not know for several decades, but the hypothesis seems likely to some degree.
You can reduce your small chance of developing HPV-related cancers dramatically by eating healthy foods, by not smoking, by limiting your sexual partners, and by undergoing regular screenings. 95 percent of cases of HPV are currently shrugged off by the body. You should consider your lifestyle honestly when making a risk/benefit analysis.
Gardasil may offer some further protection. After 3.6 years, the results from two randomized, placebo-controlled trials following 17,622 women who were vaccinated with Gardasil after showing no previous exposure to 14 HPV types and had normal Pap smears to begin with were:
· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significanceassociated with a high-risk type of HPV
· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion
· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion
· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion
Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.
Protection against genital warts appears to be extremely good.
We do not know whether replacement diseases will occur should non-vaccine strains of the virus (there are more than 100, and at least 15 are known to be oncogenic) fill the biological niche left by vaccine strains. We do not believe that this is likely but the vaccine Prevnar has shown that it can happen.
We do not know how Gardasil will affect natural immunity to the more than 100 strains of HPV.
We do not know how long immunity will last and whether single, or perhaps multiple, booster shots will be necessary. We do not know whether, should immunity to HPV-16 and HPV-18 wear off, older adults will be able to fight off the virus as well as younger adults.
Data from the passive VAERS system that is used to monitor vaccine adverse events, along with data from clinical trials, appears to indicate that Gardasil is well-tolerated by the vast majority of individuals. The FDA has determined a slightly greater risk of fainting and associated injury and of blood clots.
Anecdotal evidence and VAERS reports associate Gardasil with an increased risk of auto-immune disease and neurological problems, including rapid-onset ALS, arthritis, Graves Disease, paralysis, seizures, chronic headache, etc., predominantly in very active girls, but no causal link has been found at this time and incidence does not occur at a very significantly greater rate than in the general population. Incidence of auto-immune disease, which may be triggered in genetically pre-disposed individuals and more often in women by environmental factors, is generally rising. We do not know why. We do not know if a rapidly increasing lifetime burden of vaccine adjuvants plays some part, although high levels of aluminum have reportedly been found in spinal taps from some affected girls.
There was concern that initial studies of Gardasil showed a 44.6 percent increase in CIN 2/3 (the highest grade of pre-cancerous lesion) in a sub-group of individuals who had existing vaccine-type infections at time of vaccination. Further analysis showed that an unbalanced proportion of these subjects may have had enhanced risk factors such as a current smoking habit or a history of cervicovaginal infection or STD. Background evidence provided to the committee approving Gardasil concluded that, after balancing risk factors and sub-dividing sub-groups, vaccination could be said to reduce CIN2/3 by a modest 5.5 percent. Overall, a combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent in subjects who tested positive for vaccine-relevant HPV at the beginning of the study.
You may wish to get an HPV test and/or a pregnancy test prior to vaccination. You may wish discuss the advisability of vaccination with your doctor if you or your family has a history of autoimmune disorders.
You should not get Gardasil if you’re allergic to yeast or if you’re pregnant or planning to become pregnant soon.
You should report any and all potential adverse reactions to VAERS, being sure to include valid contact information, and not just all immediately post-vaccination allergic reactions, as the CDC’s handout implies.
Friday, August 21, 2009
JAMA Nails the Problem with Gardasil — and Our Healthcare System
With all the debate about the state of American health care going on, it’s interesting that this month’s Journal of the American Medical Association (JAMA) has—perhaps unintentionally—presented the Gardasil vaccine against the HPV virus as a microcosm of what’s wrong with our current system. Over-prescribing, “skewed” information for doctors, “surrogate endpoint” approval that can lead to ineffective or harmful drugs, irrational risk/benefit scenarios that are influenced by financial interests, medication rather than intelligent living—sound familiar?
More health care for those who don’t need it.
American health care, for those who can afford it, is often as excessive as a Hardee’s Thickburger. The Congressional Budget Office estimates that 700 billion per year, or 5 percent of the US GDP, goes to tests and procedures that don’t improve health outcomes in the least.
Drs. Sheila and David Rothman note that in “creating a market out of thin air,” as PharmExec aptly put it when naming Gardasil 2007 Brand of the Year, Merck’s HPV vaccine was pushed to the entire population, rather than to those who really need it.
Cervical cancer kills around 4,000 people every year in the US. The death rate has dropped impressively since annual Pap smears were introduced in the 50s, and continues to drop by about four percent each year. Indeed, a large percentage of deaths from cervical cancer can be attributed to lack of access to, or inattention to, routine health care. Roughly 40 percent of women in the US are unwilling or unable to get regular Pap smears, and Kaiser Permanente found that more than half of its members with cervical cancer had not done so.
The Gardasil campaign, say the Rothmans, “bypassed public health officials who would have spear-headed a risk-sensitive vaccination campaign…this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable. It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the south, Latinos along the Texas-Mexico border and whites in Appalachia, the marketing campaign posited that every girl was at equal risk.”
At least impoverished girls in the regions the Rothmans describe can sometimes get the shots at taxpayer expense. Women in the developing world, alas, are far more vulnerable to cervical cancer than the average American woman; it is the leading cause of cancer-related deaths among women there and kills some 215,475 women annually. Limited or non-existent access to routine health care means that an HPV vaccine would probably be well worth the small risk—but it’s currently unaffordable.
One of the more compelling arguments for the current private health care system in the US is that without being able to eye the highly lucrative American market, many lifesaving technologies and medications would never be developed and implemented around the world. It’s possible…maybe…that Merck has it in mind to pay for Gardasil development costs and huge profit margins by over-selling to the American market—at $360 plus administration costs per kid—and then offer the vaccine at a fractional cost to the market that actually needs it.
Oops. Maybe not. In India the series runs at about $173; far, far out of reach for the average woman in a country where 42 percent of the population lives below the international poverty level of $1.25/day. Absent a massively expensive and ill-afforded government program, only the rich, who already have access to preventive health care, are able to get it. And with a population of 1.2 billion, any government program will necessarily have limited coverage.
Then again, Americans have to ask ourselves about the morality of injecting substances into our children partly in order to defray the cost of overseas health care, if that’s what we’re looking at. There’s a big difference between subsidizing MRI technology with your money and subsidizing a vaccination with your child’s body.
Better living through chemistry.
We Americans (and increasingly other nations, too) have shown that we’re willing to be told that pills, potions, and now vaccinations are a convenient answer to epidemics like Type 2 diabetes, heart disease, ADD and now HPV. Way better, in fact, than taking responsibility for our own health and using medications only as a last resort. We’re apparently quite willing to transfer our dollars from the farmers’ market to the pharmaceutical market.
What the Rothmans didn’t say: A good deal of the potential physical trauma caused by persistent (not transient) HPV infection can be avoided by lifestyle changes, particularly if they’re made early. People who smoke, eat a lousy diet with a tiny or non-existent vegetable/fruit component, and/or have multiple sexual partners, are at a dramatically greater risk of getting a persistent HPV infection that might lead to abnormal cervical cells. A healthy immune system enables people to shrug off the vast majority of highly prevalent HPV infections. Your initially tiny risk of getting a persistent infection increases by as much as 15 percent with each sexual partner, by at least 50 percent with a bad diet, and by up to 2,600 percent with a smoking habit. But Merck is not inclined to tell you that, and neither are most doctors—or at least, not with the same force that they’ll put into the vaccination sales job.
Who cares about ultimate effectiveness? Just approve it already!
The FDA commonly accepts “surrogate endpoints” when approving drugs. Because it can take too long and cost too much to take drug trials to the ultimate outcome, and because doing so could deprive other patients from potentially life-saving treatments, the FDA often looks instead at interim markers. For instance, it might approve a drug because it lowers blood pressure rather than waiting to see how many people in the study die of a stroke instead of sheer old age.
That’s very reasonable—except that we are then often “surprised” by the ineffectiveness or negative side effects of drugs like Avandia, Vytorin, Zetia, Vioxx. Medications are effective for some 60 percent of treated patients at best.
The approval of Gardasil was an even bigger jump than usual. The assumption was that if we can defeat the two oncogenic strains of HPV that are responsible for 70 percent of cases of cervical cancer, then we can reduce the number of cases by 70 percent. That’s how it’s sold to parents, at least by implication.
“No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18 ‘other strains may emerge as significant oncogenic serotypes,’” note the Rothmans.
The last trial data showed Gardasil to be 17-45 percent effective in preventing pre-cancerous cells, with the most dangerous types at the lower end of the range. It is too early to tell much about potential replacement diseases and longevity. When a healthy system shrugs off a particular HPV strain, it virtually always retains a life-long immunity to infection with that type; we’re many years from knowing that about Gardasil and from understanding the implications of an infection in later years. Plus, the many oncogenic HPV strains not covered by Gardasil may move into the post-vaccination void. We just don’t know yet.
The FDA has also been curiously incurious about the growing burden of vaccines on developing bodies. At 50, I’ve had few vaccines in my life, and those mostly later; today’s average child will have had 26 by the time he’s just two years old. And they just keep coming. Spurred by the blockbuster success of Gardasil, there’s wild speculation in the vaccine industry and several new vaccines are well along in development.
Although the FDA requires “concomitant use” studies to prove that a new vaccine doesn’t affect the safety or effectiveness of existing vaccines given at the same time, little or no attention is given to the total lifetime burden of adjuvants like aluminum injected directly into the circulatory and lymphatic system. Some girls who have been hit with post-Gardasil autoimmune issues have been given lumbar punctures, which have revealed “high” levels of aluminum.
It’s all about the marketing/money, baby.
An even bigger jump was Merck’s saturation of the airwaves and doctors’ offices with the message that, as consumers inevitably inferred, not getting Gardasil equals cervical cancer. And here’s where the Rothmans really got going.
Their article lashed the professional medical associations (PMAs) that took Merck’s money to promote Gardasil to other health professionals—notably the American Society for Colposcopy and Cervical Pathology, the Society of Gynecologic Oncologists, and the American College Health Association.
The campaign was a shocking piece of marketing, and “that these arguments were delivered by PMAs is cause for concern,” wrote the Rothmans. “(PMAs) are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients. To this end, PMAs must become more transparent about their relationship with industry, disclosing both the precise funding and technical assistance they have received to develop the promotional products. Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor” (as actually happened).
Well, color me surprised. Pharma’s aggressive marketing techniques and slanted information have long permeated the entire medical profession.
A UCSF study found that doctors frequently make decisions about which drugs to prescribe based on “skewed” reports that are essentially written by the drug companies and then published in medical journals, typically emphasizing the positive reports of the trials and selectively reporting data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published. There were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after FDA approval.
Then there was the revelation that Merck had published an entire medical fake journal to push its products as well as keeping a list of researchers and doctors to be ‘discredited’ or ‘neutralized.’
Next, a UM study that found that researchers often didn’t properly disclose potential conflicts of interest in cancer studies. Where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.
Frankly, it’s a wonder that anyone trusts the medical industry at all. And that’s a shame. Good doctors, good researchers, imaginative and disciplined scientists, and effective, life-saving medications and treatments abound, but they’re drowned out by the shrill clamor of—shills.
Risk/benefit assessment
We all resent doctors who think they’re God, but we let them take on that role when we are not given, or do not search out, sufficient information. We should be able to trust them, but sometimes we can’t. Sometimes they themselves get skewed info.
Here’s how Dr. Charlotte Haug sums up Gardasil in JAMA. “If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally, she should be willing to accept only a small risk of harmful effects from the vaccine.
“When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put in the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.”
And they’re not. As Deborah Kotz reported in the US News and World Report yesterday, 68 percent of reports of adverse events were filed in the VAERS system by Merck itself, and 89 percent didn't include "sufficient identifying information to allow medical review of the individual cases." The VAERS passive reporting system is notoriously fallible.
Kotz goes on to say that the results of the autopsy of Jenny Tetlock, who died of a mystery progressive paralysis after getting her Gardasil shots, showed that Jenny died from a “neurological disease that was ‘mediated by immune responses,’ leading to extensive damage in her spinal cord.” Her tissue samples will now be compared with those of Whitney Baird, who died of similar problems, but whose illness was never noted in the VAERS data base until Jenny’s case hit the internet.
It gave me great joy to read Dr. Haug’s words about rationally looking at the risk/reward ratio of Gardasil. I’ve been trying to look at the vaccine rationally since 2006, but maybe now that Dr. Haug,the Rothmans and JAMA have weighed in, our pediatrician will stop saying I’m an idiot for doing so.
Now if we can only apply the lessons to our healthcare system.
More health care for those who don’t need it.
American health care, for those who can afford it, is often as excessive as a Hardee’s Thickburger. The Congressional Budget Office estimates that 700 billion per year, or 5 percent of the US GDP, goes to tests and procedures that don’t improve health outcomes in the least.
Drs. Sheila and David Rothman note that in “creating a market out of thin air,” as PharmExec aptly put it when naming Gardasil 2007 Brand of the Year, Merck’s HPV vaccine was pushed to the entire population, rather than to those who really need it.
Cervical cancer kills around 4,000 people every year in the US. The death rate has dropped impressively since annual Pap smears were introduced in the 50s, and continues to drop by about four percent each year. Indeed, a large percentage of deaths from cervical cancer can be attributed to lack of access to, or inattention to, routine health care. Roughly 40 percent of women in the US are unwilling or unable to get regular Pap smears, and Kaiser Permanente found that more than half of its members with cervical cancer had not done so.
The Gardasil campaign, say the Rothmans, “bypassed public health officials who would have spear-headed a risk-sensitive vaccination campaign…this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable. It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the south, Latinos along the Texas-Mexico border and whites in Appalachia, the marketing campaign posited that every girl was at equal risk.”
At least impoverished girls in the regions the Rothmans describe can sometimes get the shots at taxpayer expense. Women in the developing world, alas, are far more vulnerable to cervical cancer than the average American woman; it is the leading cause of cancer-related deaths among women there and kills some 215,475 women annually. Limited or non-existent access to routine health care means that an HPV vaccine would probably be well worth the small risk—but it’s currently unaffordable.
One of the more compelling arguments for the current private health care system in the US is that without being able to eye the highly lucrative American market, many lifesaving technologies and medications would never be developed and implemented around the world. It’s possible…maybe…that Merck has it in mind to pay for Gardasil development costs and huge profit margins by over-selling to the American market—at $360 plus administration costs per kid—and then offer the vaccine at a fractional cost to the market that actually needs it.
Oops. Maybe not. In India the series runs at about $173; far, far out of reach for the average woman in a country where 42 percent of the population lives below the international poverty level of $1.25/day. Absent a massively expensive and ill-afforded government program, only the rich, who already have access to preventive health care, are able to get it. And with a population of 1.2 billion, any government program will necessarily have limited coverage.
Then again, Americans have to ask ourselves about the morality of injecting substances into our children partly in order to defray the cost of overseas health care, if that’s what we’re looking at. There’s a big difference between subsidizing MRI technology with your money and subsidizing a vaccination with your child’s body.
Better living through chemistry.
We Americans (and increasingly other nations, too) have shown that we’re willing to be told that pills, potions, and now vaccinations are a convenient answer to epidemics like Type 2 diabetes, heart disease, ADD and now HPV. Way better, in fact, than taking responsibility for our own health and using medications only as a last resort. We’re apparently quite willing to transfer our dollars from the farmers’ market to the pharmaceutical market.
What the Rothmans didn’t say: A good deal of the potential physical trauma caused by persistent (not transient) HPV infection can be avoided by lifestyle changes, particularly if they’re made early. People who smoke, eat a lousy diet with a tiny or non-existent vegetable/fruit component, and/or have multiple sexual partners, are at a dramatically greater risk of getting a persistent HPV infection that might lead to abnormal cervical cells. A healthy immune system enables people to shrug off the vast majority of highly prevalent HPV infections. Your initially tiny risk of getting a persistent infection increases by as much as 15 percent with each sexual partner, by at least 50 percent with a bad diet, and by up to 2,600 percent with a smoking habit. But Merck is not inclined to tell you that, and neither are most doctors—or at least, not with the same force that they’ll put into the vaccination sales job.
Who cares about ultimate effectiveness? Just approve it already!
The FDA commonly accepts “surrogate endpoints” when approving drugs. Because it can take too long and cost too much to take drug trials to the ultimate outcome, and because doing so could deprive other patients from potentially life-saving treatments, the FDA often looks instead at interim markers. For instance, it might approve a drug because it lowers blood pressure rather than waiting to see how many people in the study die of a stroke instead of sheer old age.
That’s very reasonable—except that we are then often “surprised” by the ineffectiveness or negative side effects of drugs like Avandia, Vytorin, Zetia, Vioxx. Medications are effective for some 60 percent of treated patients at best.
The approval of Gardasil was an even bigger jump than usual. The assumption was that if we can defeat the two oncogenic strains of HPV that are responsible for 70 percent of cases of cervical cancer, then we can reduce the number of cases by 70 percent. That’s how it’s sold to parents, at least by implication.
“No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18 ‘other strains may emerge as significant oncogenic serotypes,’” note the Rothmans.
The last trial data showed Gardasil to be 17-45 percent effective in preventing pre-cancerous cells, with the most dangerous types at the lower end of the range. It is too early to tell much about potential replacement diseases and longevity. When a healthy system shrugs off a particular HPV strain, it virtually always retains a life-long immunity to infection with that type; we’re many years from knowing that about Gardasil and from understanding the implications of an infection in later years. Plus, the many oncogenic HPV strains not covered by Gardasil may move into the post-vaccination void. We just don’t know yet.
The FDA has also been curiously incurious about the growing burden of vaccines on developing bodies. At 50, I’ve had few vaccines in my life, and those mostly later; today’s average child will have had 26 by the time he’s just two years old. And they just keep coming. Spurred by the blockbuster success of Gardasil, there’s wild speculation in the vaccine industry and several new vaccines are well along in development.
Although the FDA requires “concomitant use” studies to prove that a new vaccine doesn’t affect the safety or effectiveness of existing vaccines given at the same time, little or no attention is given to the total lifetime burden of adjuvants like aluminum injected directly into the circulatory and lymphatic system. Some girls who have been hit with post-Gardasil autoimmune issues have been given lumbar punctures, which have revealed “high” levels of aluminum.
It’s all about the marketing/money, baby.
An even bigger jump was Merck’s saturation of the airwaves and doctors’ offices with the message that, as consumers inevitably inferred, not getting Gardasil equals cervical cancer. And here’s where the Rothmans really got going.
Their article lashed the professional medical associations (PMAs) that took Merck’s money to promote Gardasil to other health professionals—notably the American Society for Colposcopy and Cervical Pathology, the Society of Gynecologic Oncologists, and the American College Health Association.
The campaign was a shocking piece of marketing, and “that these arguments were delivered by PMAs is cause for concern,” wrote the Rothmans. “(PMAs) are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients. To this end, PMAs must become more transparent about their relationship with industry, disclosing both the precise funding and technical assistance they have received to develop the promotional products. Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor” (as actually happened).
Well, color me surprised. Pharma’s aggressive marketing techniques and slanted information have long permeated the entire medical profession.
A UCSF study found that doctors frequently make decisions about which drugs to prescribe based on “skewed” reports that are essentially written by the drug companies and then published in medical journals, typically emphasizing the positive reports of the trials and selectively reporting data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published. There were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after FDA approval.
Then there was the revelation that Merck had published an entire medical fake journal to push its products as well as keeping a list of researchers and doctors to be ‘discredited’ or ‘neutralized.’
Next, a UM study that found that researchers often didn’t properly disclose potential conflicts of interest in cancer studies. Where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.
Frankly, it’s a wonder that anyone trusts the medical industry at all. And that’s a shame. Good doctors, good researchers, imaginative and disciplined scientists, and effective, life-saving medications and treatments abound, but they’re drowned out by the shrill clamor of—shills.
Risk/benefit assessment
We all resent doctors who think they’re God, but we let them take on that role when we are not given, or do not search out, sufficient information. We should be able to trust them, but sometimes we can’t. Sometimes they themselves get skewed info.
Here’s how Dr. Charlotte Haug sums up Gardasil in JAMA. “If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally, she should be willing to accept only a small risk of harmful effects from the vaccine.
“When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put in the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.”
And they’re not. As Deborah Kotz reported in the US News and World Report yesterday, 68 percent of reports of adverse events were filed in the VAERS system by Merck itself, and 89 percent didn't include "sufficient identifying information to allow medical review of the individual cases." The VAERS passive reporting system is notoriously fallible.
Kotz goes on to say that the results of the autopsy of Jenny Tetlock, who died of a mystery progressive paralysis after getting her Gardasil shots, showed that Jenny died from a “neurological disease that was ‘mediated by immune responses,’ leading to extensive damage in her spinal cord.” Her tissue samples will now be compared with those of Whitney Baird, who died of similar problems, but whose illness was never noted in the VAERS data base until Jenny’s case hit the internet.
It gave me great joy to read Dr. Haug’s words about rationally looking at the risk/reward ratio of Gardasil. I’ve been trying to look at the vaccine rationally since 2006, but maybe now that Dr. Haug,the Rothmans and JAMA have weighed in, our pediatrician will stop saying I’m an idiot for doing so.
Now if we can only apply the lessons to our healthcare system.
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?
Friday, May 8, 2009
Cervarix versus Gardasil
The battle’s on. And let the marketing campaigns and medical sniping begin.
GlaxoSmithKline said today that the results of a comparative HPV vaccine study it had sponsored showed that Cervarix generated between two and six times as many antibodies as Gardasil.
Both vaccines utilize novel “virus-like particles,” VLPs. These are created by inserting DNA into yeast cells to make a genetically-engineered ‘seed stock’. The resulting paste is cultured in a fermenter to increase cell mass and then incubated; eventually the antigen VLPs are filtered from the paste and blended with adjuvants. The paste is then cleaned and reused.
Both vaccines protect against HPV strains 16 and 18, thought to be responsible for 66 to 70 percent of cervical cancers, although one study recently showed 16 to have been losing ground to strains other than 18 (there are believed to be up to 120 strains of HPV) for some years. Gardasil also protects against two wart-causing strains.
But Cervarix also uses a novel adjuvant containing aluminium salt and monophosphoryl lipid A (MPL), and according to GSK that makes a big difference in antibody levels—a claim that made a Merck spokesman sniff disparagingly, “It's disease efficacy that's really the most important, and we certainly have very high efficacy against some very important disease endpoints."
Cervarix has been used in the EU for some time and was chosen over Gardasil by Britain for its country-wide vaccination program. However, the FDA is currently looking it over for approval in the US, where Merck has had the market to itself up until now.
Both vaccines have been associated with side-effects including paralysis, convulsions and immune disorders, although no causal link has been proven and the CDC beleives that HPV vaccines are safe.
Approval for Cervarix in the US could come by the fall—so if you think the Gardasil campaign up to now has been aggressive, honey, you ain’t seen nothin’ yet.
GlaxoSmithKline said today that the results of a comparative HPV vaccine study it had sponsored showed that Cervarix generated between two and six times as many antibodies as Gardasil.
Both vaccines utilize novel “virus-like particles,” VLPs. These are created by inserting DNA into yeast cells to make a genetically-engineered ‘seed stock’. The resulting paste is cultured in a fermenter to increase cell mass and then incubated; eventually the antigen VLPs are filtered from the paste and blended with adjuvants. The paste is then cleaned and reused.
Both vaccines protect against HPV strains 16 and 18, thought to be responsible for 66 to 70 percent of cervical cancers, although one study recently showed 16 to have been losing ground to strains other than 18 (there are believed to be up to 120 strains of HPV) for some years. Gardasil also protects against two wart-causing strains.
But Cervarix also uses a novel adjuvant containing aluminium salt and monophosphoryl lipid A (MPL), and according to GSK that makes a big difference in antibody levels—a claim that made a Merck spokesman sniff disparagingly, “It's disease efficacy that's really the most important, and we certainly have very high efficacy against some very important disease endpoints."
Cervarix has been used in the EU for some time and was chosen over Gardasil by Britain for its country-wide vaccination program. However, the FDA is currently looking it over for approval in the US, where Merck has had the market to itself up until now.
Both vaccines have been associated with side-effects including paralysis, convulsions and immune disorders, although no causal link has been proven and the CDC beleives that HPV vaccines are safe.
Approval for Cervarix in the US could come by the fall—so if you think the Gardasil campaign up to now has been aggressive, honey, you ain’t seen nothin’ yet.
Thursday, May 7, 2009
The Gardasil Campaign Picks Up Some of Merck’s ‘Hit List’ Strategies.
It’s a classic case of, if you’re not white-hot with rage, you’re sure as heck not paying attention.
Last month The Australian reported that Julian Burnside QC (Queen’s Counsel) had produced in court internal Merck emails that contained a ‘hit list’ of doctors, researchers and academics it needed to neutralize or discredit. In some cases it was noted that a doctor had already been neutralized. “We may need to seek them out and destroy them where they live,” it read. (One can only assume that the advice was not meant to be taken Mafia-style.)
Why discredit these people? Because they had criticized Vioxx or Merck.
Now it turns out that New Zealand’s Health Ministry may have picked up a few tips from Merck.
Just to refresh your memory, the Merck e-mails were presented in a class-action lawsuit against Merck over its anti-inflammatory drug Vioxx. Julian Burnside also produced evidence that Merck had attempted to intimidate researchers with implied threats of funding cut-offs or withdrawn academic appointments. An infuriated James Fries, professor of medicine at Stanford University, had apparently written to Merck back in 2000 to complain about the way it had treated some of his researchers who had been critical of Vioxx.
“Even worse were allegations of Merck damage control by intimidation…This has happened to at least eight (clinical) investigators ... I suppose I was mildly threatened myself…”
Specific incidences of intimidation included one of Fries’ colleagues’ belief that his position had been put in jeopardy, and phone calls to another alleging his “anti-Merck” bias. Fries apparently told Merck that it had been ‘systematically playing down the side effects of Vioxx’ and that its behavior "seriously impinges on academic freedom."
"In every possible way the company exerted itself to present the impression to the world at large that Vioxx did not provide any increased cardio risk ... when (a) it probably would and (b) it probably did," the letter went on to say.
So, on to Gardasil and New Zealand’s Ministry of Health.
New Zealand is having a bit of a problem with implementing its country-wide Gardasil vaccination program. The 3-shot HPV vaccine is being administered through schools, and 78 schools, about 5 percent, have declined to take part.
Furthermore, New Zealand’s self-described “leading health and fitness magazine” Fitness Life produced an article critical of Gardasil because, according to the publisher, the drug had been heavily promoted by a glowingly positive Ministry of Health and Merck, and no-one had publicly discussed potential long-term effects.
The article was publicized with a billboard in the middle of Auckland. The Ministry of Health promptly filed a complaint with the Advertising Standards Authority (ASA) on the grounds that both billboard and article were “misleading, deceptive, and irresponsible.”
The magazine countered that it would be deceptive and irresponsible to “only talk Gardasil up, regardless of possible side-effects…The advertisement and article were commissioned with a keen sense of social responsibility and with the hope that, by asking entirely valid questions, we are opening the floor to fresh debate on an issue that is of great importance to families and their daughters.”
Fair enough. The ASA agreed on all counts and threw out the MoH’s complaint.
Now, here’s where it gets interesting.
The MoH’s next cannon-ball was a written response to the article, available online, from the Immunisation Advisory Center.
After an unprofessionally snarky introduction, it counters some errors, such as a statement in the Fitness Life article that Gardasil contains a dead virus (it’s neither dead nor alive; it in fact uses a new genetically-engineered process that produces “virus-like particles”). It clears up some “confusions” and reiterates the CDC’s stance that, regardless of VAERS data (which is raw and often unverified data, both under-reported and over-reported) Gardasil “has not been found to increase the risk of any of the serious conditions (other than anaphylaxis) noted in Wheaton’s article.”
I’m certainly not opposed to correcting statements of fact. As a writer, I do my damndest to get my facts straight, and I’m happy to correct any factual error that I might make. I get positively crabby, actually, when people do the Chinese-whispers thing with some fairly outrageous suggestions—and that certainly has been known to happen with Gardasil. Because Fitness Life is not online, I have no clue what the article actually said.
But what sticks in my craw, apart from the pettish tone of the response, is the rather blatant attempt to shut down debate.
And what really, truly sticks in my craw like a bowling ball in a drinking straw. is the little zinger at the end.
“A note on Diane Harper: After involvement with Merck and Gardasil clinical trials, Diane Harper disappeared and was found working for GSK on the Cervarix clinical trials. Her position on Gardasil may not be neutral.”
Wow. That comes straight out of Merck’s playbook.
I don’t know Harper from Adam. But I’ve liked the seemingly very realistic and sensible statements I’ve heard from her. She has said, pretty much, that Gardasil is a great vaccine that is very valuable for most women, BUT that it was marketed too aggressively, introduced too rapidly, and could be a no-no for people with a family or personal history of auto-immune disorder. In other words, she’d have liked to see Merck and medical authorities proceeding a little more cautiously with a brand-new vaccine. Which sounds completely reasonable to me.
Oh wait. It’s partially critical.
So let’s discredit her.
Yep. Sounds like good old New Zealand has been getting some advice from Merck.
Last month The Australian reported that Julian Burnside QC (Queen’s Counsel) had produced in court internal Merck emails that contained a ‘hit list’ of doctors, researchers and academics it needed to neutralize or discredit. In some cases it was noted that a doctor had already been neutralized. “We may need to seek them out and destroy them where they live,” it read. (One can only assume that the advice was not meant to be taken Mafia-style.)
Why discredit these people? Because they had criticized Vioxx or Merck.
Now it turns out that New Zealand’s Health Ministry may have picked up a few tips from Merck.
Just to refresh your memory, the Merck e-mails were presented in a class-action lawsuit against Merck over its anti-inflammatory drug Vioxx. Julian Burnside also produced evidence that Merck had attempted to intimidate researchers with implied threats of funding cut-offs or withdrawn academic appointments. An infuriated James Fries, professor of medicine at Stanford University, had apparently written to Merck back in 2000 to complain about the way it had treated some of his researchers who had been critical of Vioxx.
“Even worse were allegations of Merck damage control by intimidation…This has happened to at least eight (clinical) investigators ... I suppose I was mildly threatened myself…”
Specific incidences of intimidation included one of Fries’ colleagues’ belief that his position had been put in jeopardy, and phone calls to another alleging his “anti-Merck” bias. Fries apparently told Merck that it had been ‘systematically playing down the side effects of Vioxx’ and that its behavior "seriously impinges on academic freedom."
"In every possible way the company exerted itself to present the impression to the world at large that Vioxx did not provide any increased cardio risk ... when (a) it probably would and (b) it probably did," the letter went on to say.
So, on to Gardasil and New Zealand’s Ministry of Health.
New Zealand is having a bit of a problem with implementing its country-wide Gardasil vaccination program. The 3-shot HPV vaccine is being administered through schools, and 78 schools, about 5 percent, have declined to take part.
Furthermore, New Zealand’s self-described “leading health and fitness magazine” Fitness Life produced an article critical of Gardasil because, according to the publisher, the drug had been heavily promoted by a glowingly positive Ministry of Health and Merck, and no-one had publicly discussed potential long-term effects.
The article was publicized with a billboard in the middle of Auckland. The Ministry of Health promptly filed a complaint with the Advertising Standards Authority (ASA) on the grounds that both billboard and article were “misleading, deceptive, and irresponsible.”
The magazine countered that it would be deceptive and irresponsible to “only talk Gardasil up, regardless of possible side-effects…The advertisement and article were commissioned with a keen sense of social responsibility and with the hope that, by asking entirely valid questions, we are opening the floor to fresh debate on an issue that is of great importance to families and their daughters.”
Fair enough. The ASA agreed on all counts and threw out the MoH’s complaint.
Now, here’s where it gets interesting.
The MoH’s next cannon-ball was a written response to the article, available online, from the Immunisation Advisory Center.
After an unprofessionally snarky introduction, it counters some errors, such as a statement in the Fitness Life article that Gardasil contains a dead virus (it’s neither dead nor alive; it in fact uses a new genetically-engineered process that produces “virus-like particles”). It clears up some “confusions” and reiterates the CDC’s stance that, regardless of VAERS data (which is raw and often unverified data, both under-reported and over-reported) Gardasil “has not been found to increase the risk of any of the serious conditions (other than anaphylaxis) noted in Wheaton’s article.”
I’m certainly not opposed to correcting statements of fact. As a writer, I do my damndest to get my facts straight, and I’m happy to correct any factual error that I might make. I get positively crabby, actually, when people do the Chinese-whispers thing with some fairly outrageous suggestions—and that certainly has been known to happen with Gardasil. Because Fitness Life is not online, I have no clue what the article actually said.
But what sticks in my craw, apart from the pettish tone of the response, is the rather blatant attempt to shut down debate.
And what really, truly sticks in my craw like a bowling ball in a drinking straw. is the little zinger at the end.
“A note on Diane Harper: After involvement with Merck and Gardasil clinical trials, Diane Harper disappeared and was found working for GSK on the Cervarix clinical trials. Her position on Gardasil may not be neutral.”
Wow. That comes straight out of Merck’s playbook.
I don’t know Harper from Adam. But I’ve liked the seemingly very realistic and sensible statements I’ve heard from her. She has said, pretty much, that Gardasil is a great vaccine that is very valuable for most women, BUT that it was marketed too aggressively, introduced too rapidly, and could be a no-no for people with a family or personal history of auto-immune disorder. In other words, she’d have liked to see Merck and medical authorities proceeding a little more cautiously with a brand-new vaccine. Which sounds completely reasonable to me.
Oh wait. It’s partially critical.
So let’s discredit her.
Yep. Sounds like good old New Zealand has been getting some advice from Merck.
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.
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