Twitter
FacebookA better vaccine?
By Marilyn Smulders - May 21, 2009
 |
| The Clinical Trials Research Centre is investigating a new HPV vaccine. |
Researchers at the Clinical Trials Research Centre are seeking young women to participate in a study testing a new HPV vaccine. More than 150 women between the ages of 16 and 26 are needed for the four-year study.
The human papillomavirus (HPV) is a common virus transmitted through genital skin-to-skin contact. Seventy-five per cent of Canadians will have at least one HPV infection in their lifetime. Most never know they have been infected. The virus can lead to warts, abnormal pap tests, or even cervical cancer.
Vaccination to prevent HPV infection is the best way to prevent genital warts and cervical cancer. The only available vaccine that protects against cervical cancer is Gardasil, approved by Health Canada in July 2006. Gardasil protects against four of the most common types of HPV—types 6, 11, 16 and 18. HPV types 16 and 18 are high-risk types and cause approximately 70 per cent of cervical cancers. HPV types 6 and 11 are low-risk types and cause approximately 90 per cent of external genital warts.
Like Gardasil, the new vaccine being studied is from the pharmaceutical company Merck. But this vaccine may be able to protect against five more strains of HPV, “potentially providing protection against an additional 10 per cent of cervical cancers,” says Dr. Shelly McNeil, an Infectious Diseases specialist at the Queen Elizabeth II Health Sciences Centre and vaccine researcher with the Clinical Trials Research Centre.
“The women who participate will be randomized to receive either Gardasil or the new study vaccine,” adds Dr. McNeil. “No one will receive a placebo; they would at least receive Gardasil.”
In 2007-08 academic year, the provincial government set up a publicly funded program for girls in Grade 7 to receive three doses of the HPV vaccine over a six-month period. Starting this fall, the HPV vaccine will also be offered to female students in Grade 10.
Outside of the provincial program, women who would like to receive the vaccine have to pay for it themselves. But it’s costly: the three doses of the vaccine cost between $400 and $500. However, by participating in the study, participants will receive the vaccine for free.
“The important issue with this trial is its long duration; we will be following volunteers for four years,” says Dr. McNeil.
The first year of the study is the busiest, requiring six visits to the Clinical Trials Research Centre, says research coordinator Robyn McCall-Sani. In the subsequent three years, volunteers will need to visit the centre, located on the fourth floor of the Goldbloom Pavillion at the IWK Children’s Centre, for twice-a-year pap tests.
Women who are interested in participating in the study should contact Ms. McCall-Sani by phoning 470-7839 or by email at robyn.sani@iwk.nshealth.ca.
The Clinical Trials Research Centre is a division of the Canadian Center for Vaccinology, a multidisciplinary research group based at Dalhousie University, the IWK Health Centre, and Capital Health.
Readers Say
May 21, 2009 9:19 AM
May 21, 2009 9:19 AM
May 21, 2009 11:59 AM
What Are the Key Statistics About Cervical Cancer? via American Cancer Society website Human Papillomaviruses:Natural History and Virology, Elizabeth R. Unger Ph.D.,M.D. via FDA website
NIH Technology Licensed to Merck for HPV Vaccine via NIH Office of Technology Transfer website
FDA Press Release P06-77: FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus Christensen ND (2005). "Cottontail rabbit papillomavirus (CRPV) model system to test antiviral and immunotherapeutic strategies". Antivir.
Chem. Chemother. 16 (6): 355-62. PMID 16331841
Calleja-Macias IE, Villa LL, Prado JC, et al (2005). "Worldwide genomic diversity of the high-risk human papillomavirus types 31, 35, 52, and 58, four close relatives of human papillomavirus type 16". J. Virol.
79(21):13630-40 doi:10.1128/JVI.79.21.13630-13640.2005. PMID 16227283
RECLASSIFICATION PETITION FOR Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection via FDA website
May 21, 2009 12:27 PM
drug will also cause the adverse side effects as thousands of girls are now experiencing all over the world. Before you vaccinate, please research.
May 21, 2009 1:14 PM
May 21, 2009 1:40 PM
Occurrence rates of life-threatening conditions are not significantly higher in recipients of the vaccine than in the general population. As such, the potential 70% prevention rate of cervical cancer seems to outweigh the risk.
I can't post a link to the CDC site, but if you Google "cdc vaccine safety gardasil" it will be the first result. The site also offers a pdf with the raw statistical data from VAERS. If you go to the Wikipedia page on Gardasil, you can also find links to a host of authoritative websites on the safety of the vaccine.
May 21, 2009 3:32 PM
May 21, 2009 13:40 (Atlantic)
Freda: According to the CDC, 94% of the adverse reactions reported are the type commonly associated with vaccinations. Of the remaining 6%, there is no common factor which suggests a link to the vaccine. Keep in mind also that 11,916 reports were filed in the same timeframe as 23 million doses had been distributed.
Occurrence rates of life-threatening conditions are not significantly higher in recipients of the vaccine than in the general population. As such, the potential 70% prevention rate of cervical cancer seems to outweigh the risk.
I can't post a link to the CDC site, but if you Google "cdc vaccine safety gardasil" it will be the first result. The site also offers a pdf with the raw statistical data from VAERS. If you go to the Wikipedia page on Gardasil, you can also find links to a host of authoritative websites on the safety of the vaccine.
______________________________________________________________
The CDC is almost indistinguishable from large pharmaceutical companies, much the same way in which it is hard to tell where the US Air force ends and Lockeed Martin begins. The CDC will say whatever is in the best interest of business: you can take that to the bank. Do not listen to a thing they say, do not trust their data. They will fear-monger and spread disinformation in much the same way as the WHO is doing right now.
Again, please, please, please do not throw your daughters under the bus by forcing these vaccines on them.
May 21, 2009 4:13 PM
May 21, 2009 4:13 PM
May 22, 2009 5:56 AM
May 22, 2009 5:56 AM
May 22, 2009 7:43 AM
May 22, 2009 8:10 AM
The data and research is there that documents that the HPV vaccine is dangerous to women's health. How many more women need to be adversely affected or die from this pharmaceutical madness?
holyhormones.com
May 22, 2009 9:33 AM
May 22, 2009 9:33 AM
May 22, 2009 9:37 AM
Reactive aluminum is considered toxic at 1 microgram. Each Gardasil shot has 225 micrograms (all 3 shots equal 675 micrograms!).
Along with the other toxic chemicals in Gardasil:
Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, < 7 mcg yeast protein/dose.
Do some research into those chemicals and see what you find. None of those chemicals need to be injected into anyone!
My 16 year old daughter has been injured by Gardasil. She was a healthy, active teenage girl before Gardasil was pushed on us at a routine doctor visit. After receiving 2 of the 3 shots, my daughter has experienced severe overall weakness, numbness/tingling in both legs and left arm, chest pains, racing heart, pressure in head, vision problems, back pain, abdominal pain, nausea, diarhea, weight loss, dizziness, just to name a few. She has been in the ER twice, once by ambulance for stopping breathing 3 times. She's seen several doctors. She's had a CT scan done. All tests come back normal (which is typical with all of the injured 'gardasil girls'). Her blood panel showed high on immunoglobulin E (131H) and Anti-streptolysin O (208H) which the doctor 'thought' was Rheumatic Fever. Another doctor has said he did not believe she had Rheumatic Fever.
I would love for you to look at the other side of the fence and research this. There are thousands of girls that are coming down with strange illnesses, paralysis, gran mal seizures, etc. after receiving Gardasil.
DO YOUR RESEARCH!!!!!!!!!
May 22, 2009 9:37 AM
May 22, 2009 10:54 AM
May 22, 2009 10:54 AM
May 22, 2009 11:00 AM
May 22, 2009 11:11 AM
I've done some more looking around, and while there are number of people voicing concerns about the safety of the vaccine I:
a) have trouble believing that the vaccine causes GBS, ALS, epilepsy, pulmonary embolism, cardiac arrythmia, diabetic ketoacidosis, etc. and still only cause these effects in what appears to be ~0.023% of those vaccinated.
b) am seeing a link to the similar controversy in which it has been claimed that MMR vaccines cause autism. In both cases, it is important to remember that correlation != causation.
However, I will concede that the high concentration of aluminum is worrisome, as someone pointed out. Furthermore, cervical cancer is relatively rare compared to cancers in general; the HPV strains thought to cause it are only a handful out of the several dozens of strains floating around in the population.
I guess rather than getting vaccinated for something like that, bearing in mind that there are appx. 10 million other things that could just as easily kill you, parents might be better advised to communicate with their children about sex, and advising them to take the proper precautions. That's trite, I know, but true.
Very well, I'm convinced. Not that Gardasil is necessarily hurting people, but that the vaccine seems to be almost entirely pointless, and that the neurotoxins used as preservatives are at least worrisome. People should be using barrier methods for a host of other very good reasons anyway.
May 22, 2009 12:28 PM
The document submitted to the FDA, dated June 6, 2006, in protocol 018 the ages of the participants were 9-15 boys (775) and girls (775), total number were only 1650.
On page 316 of this report, table 229, you will see that the number of clinical adverse 'experiences' is "1+ AE" (adverse experience) = 963 (82.7%)per the vaccine group.
On page 318, table 232, "clinical adverse experience", you will see that in the 9 - 12 year old group who received the vaccine was 567 (83.0%). The total number of 9 - 12 year olds in this group were only 692.
Now if you go to the closeout document to the FDA on Gardasil, dated September 11, 2008, you will see on page 76, table 41, that the total 'clinical adverse experience' of the age group 9 - 17 year olds with 1 or more 'adverse experience' was 2087 (85.9%) out of 2463 participants.
You can view these documents on the FDA website under Gardasil.
I could give you more numbers but my goal is for you to go to the FDA website and look at the documents for yourself. Educate before you vaccinate.
May 22, 2009 1:27 PM
I do not care what the CDC data says! only 1% of vaccine injuries are reported! If they would like to come live in hell they have my address...
May 22, 2009 1:27 PM
I do not care what the CDC data says! only 1% of vaccine injuries are reported! If they would like to come live in hell they have my address...
May 22, 2009 2:25 PM
In the second report, the test and control groups differ in the group ranging from ages 9-17, but not in the group ranging from 18-26. Looking at the follow-up, there don't seem to have been many long-term consequences, and no significant difference for test and control. Still, it raises the question of whether the vaccine should be given to children below a certain age.
May 22, 2009 2:25 PM
In the second report, the test and control groups differ in the group ranging from ages 9-17, but not in the group ranging from 18-26. Looking at the follow-up, there don't seem to have been many long-term consequences, and no significant difference for test and control. Still, it raises the question of whether the vaccine should be given to children below a certain age.
May 22, 2009 8:07 PM
Firstly, adverse events should be expected when you receive an injection; pain, redness, swelling all qualify as clinical adverse events. Serious adverse events (including death), however, are extremely rare. These people have taken the statistics and skewed the data to fit their own predispositions - flagrant bias. Real studies conducted by qualified people go to extremes to exclude such methodological flaws, but I suppose that's too much to ask?
They have attempted to scare you with carefully selected "horror stories", but the safety of a drug cannot be measured by looking at one single anecdote. This is like trying to predict the outcome of an election by asking one person who they're voting for. Real studies don't tell one story, they tell thousands at once.
And do the posters here actually think they are qualified to assess the need for other ingredients in Gardasil, let alone assess their toxicological profile? Why don't we call up the guy from McDonald's when we want blueprints for a new harbour bridge? Because you go to trained experts for an opinion on their area of expertise. Toxicology and biochemistry is clearly not theirs.
The beauty of conspiracy theories is that you need absolutely no proof to perpetuate them. The statistics aren't in their favour, so they claim that the studies are rigged...without any supporting evidence. To even suggest that a "conspiracy" runs that deep is an affront to dedicated health care workers and scientists (whose involvement would be required), and thus it also suggests a total lack of familiarity with the clinical process or the institutions involved.
By all means do your research, but also be honest in your ability to properly assess the information you find, lest you go around spewing nonsense on the internet.
May 22, 2009 8:07 PM
Firstly, adverse events should be expected when you receive an injection; pain, redness, swelling all qualify as clinical adverse events. Serious adverse events (including death), however, are extremely rare. These people have taken the statistics and skewed the data to fit their own predispositions - flagrant bias. Real studies conducted by qualified people go to extremes to exclude such methodological flaws, but I suppose that's too much to ask?
They have attempted to scare you with carefully selected "horror stories", but the safety of a drug cannot be measured by looking at one single anecdote. This is like trying to predict the outcome of an election by asking one person who they're voting for. Real studies don't tell one story, they tell thousands at once.
And do the posters here actually think they are qualified to assess the need for other ingredients in Gardasil, let alone assess their toxicological profile? Why don't we call up the guy from McDonald's when we want blueprints for a new harbour bridge? Because you go to trained experts for an opinion on their area of expertise. Toxicology and biochemistry is clearly not theirs.
The beauty of conspiracy theories is that you need absolutely no proof to perpetuate them. The statistics aren't in their favour, so they claim that the studies are rigged...without any supporting evidence. To even suggest that a "conspiracy" runs that deep is an affront to dedicated health care workers and scientists (whose involvement would be required), and thus it also suggests a total lack of familiarity with the clinical process or the institutions involved.
By all means do your research, but also be honest in your ability to properly assess the information you find, lest you go around spewing nonsense on the internet.
May 22, 2009 8:18 PM
Investigate as Cynthia suggested for yourself that is the best way for you to realise that what is being said is true. Children are too precious to be used as guinea pigs, please never allow that. Again thank you for being so gracious.
May 22, 2009 8:18 PM
Investigate as Cynthia suggested for yourself that is the best way for you to realise that what is being said is true. Children are too precious to be used as guinea pigs, please never allow that. Again thank you for being so gracious.
May 22, 2009 10:12 PM
May 22, 2009 10:12 PM
May 23, 2009 11:36 PM
"Cynthia: the first report you refer to seems to strengthen the case for Gardasil if anything. The additional AEs in the test group are injection site reactions; the number of systemic AEs are not significantly higher than for the non-Aluminum placebo."
In the actual Gardasil studies,if anyone here has read them, there was no obvious distinction made between aluminum-containing placebos and the supposed non-aluminum containing placebos.There was some mention made that some non-aluminum containing placebos had been used, but these were not well delineated in the study results. It was impossible to tell, from reading the studies, where and how these supposedly non-aluminum containing placebos were used, if they indeed were used. Unless that is clarified, all many of us can do is assume that most of the placebos contained aluminum. It's no wonder that some of the adverse reactions (or "events")to Gardasil involve motor neuron problems. Aluminum compounds are toxic to motor neurons.
May 23, 2009 11:36 PM
"Cynthia: the first report you refer to seems to strengthen the case for Gardasil if anything. The additional AEs in the test group are injection site reactions; the number of systemic AEs are not significantly higher than for the non-Aluminum placebo."
In the actual Gardasil studies,if anyone here has read them, there was no obvious distinction made between aluminum-containing placebos and the supposed non-aluminum containing placebos.There was some mention made that some non-aluminum containing placebos had been used, but these were not well delineated in the study results. It was impossible to tell, from reading the studies, where and how these supposedly non-aluminum containing placebos were used, if they indeed were used. Unless that is clarified, all many of us can do is assume that most of the placebos contained aluminum. It's no wonder that some of the adverse reactions (or "events")to Gardasil involve motor neuron problems. Aluminum compounds are toxic to motor neurons.
May 24, 2009 11:07 AM
May 24, 2009 11:07 AM
May 25, 2009 7:19 PM
It has probably been a year or so since I finished getting them and although I am not typically the type of person to risk getting an unnecessary vaccine I just thought I would let people know that not everybody will have an adverse affect. And giving statistics on how many people may have died from it is silly. Everybody dies of everything these days. More people have died from smoking and drinking than probably anything else and I would consider those two things to be much less necessary than a vaccine trying to protect women from disease.
So although I would not volunteer to be a test bunny for this new drug I would just like to say there are two sides to every coin. It's possible some people have already been saved from a vaccine like gardasil as well as possibly died from it, so nothing in this world is perfect. Big surprise! So if you want to get a vaccine get one, and if you don't, then don't! But let us not force our opinions on others and give out shock value bullshit statistics on how many people will die from this or that. Do what you want and deal with whatever consequences may follow.
May 25, 2009 7:19 PM
It has probably been a year or so since I finished getting them and although I am not typically the type of person to risk getting an unnecessary vaccine I just thought I would let people know that not everybody will have an adverse affect. And giving statistics on how many people may have died from it is silly. Everybody dies of everything these days. More people have died from smoking and drinking than probably anything else and I would consider those two things to be much less necessary than a vaccine trying to protect women from disease.
So although I would not volunteer to be a test bunny for this new drug I would just like to say there are two sides to every coin. It's possible some people have already been saved from a vaccine like gardasil as well as possibly died from it, so nothing in this world is perfect. Big surprise! So if you want to get a vaccine get one, and if you don't, then don't! But let us not force our opinions on others and give out shock value bullshit statistics on how many people will die from this or that. Do what you want and deal with whatever consequences may follow.
May 25, 2009 11:31 PM
You must have heard that no drug is entirely safe: not Gardasil, not Vitorin, not Zantac, not even Tylenol. 100% safety will never be acheived nor proven in a clinical setting. So why does the public still generally believe in the myth that if their doctor prescribes it, no harm will come to them?
Because the chances of a serious or fatal reaction are so low that they seem almost insignificant. The studies on Gardasil suggest an incidence of less than one severe event per 10 000 injections, which may or may not even be related to the drug. From a regulatory standpoint (FDA, CDC, or Dr. Diane Harper, your pick) that's a generally safe drug.
Despite the myth, after tens of millions of Gardasil doses, skepticism and confusion surprisingly persist. And why? Because of an outspoken minority whose continual reliance on anecdotal evidence distorts public perception.
In selecting just one story, interview, or quote, you ignore thousands more. It's subjective picking and choosing, discretionary in its nature, and it is why anecdotal evidence is unreliable from a statistical perspective. It never tells the whole story and surely the public is deserving of all the facts. The stories of the women who took the vaccine, didn't contract HPV, and didn't eventually die of cervical cancer will never be told. Their lives will have been saved, but their stories are hidden in the numbers, and people need to know that they exist, and that they should not be forgotten.
I'll give you this - HPV is preventable by other means. Whether or not the benefits outweigh the risks is a decision, I believe, best left to the patient. I am not arguing for mass public health interventions, only for informed choice.
May 26, 2009 6:00 PM