Merck’s promotion of Gardasil, its vaccine against the human papilloma virus (HPV), has a complicated history. First there was the exuberant claim about its reputedly great effectiveness in preventing cervical cancer. Now comes the recommendation last month from the Centers for Disease Control and Prevention, that all 11- and 12-year-old boys should be given the vaccine.
Of Science and Truthiness
The vaccine for boys is important, say advocates, because reducing HPV in boys will reduce transmission to girls and women—only 32 percent of whom have been getting the shots to date. Giving the shots to boys, they say, promotes gender equity. As a bonus, the vaccine may protect against oral and anal cancers in men who have sex with men.
Since a key part of the rationale for vaccinating boys is to protect girls, it’s worth a moment to examine the claims about reducing cervical cancer deaths. Merck won approval for Gardasil from the Food and Drug Administration in June 2006. On May 10, 2007, Merck published the results of a study in the New England Journal of Medicine that claimed an astounding 98 percent efficacy in preventing changes in the cervix used as a marker for cervical cancer.
But that statistic begs closer examination.
To achieve the 98 percent efficacy claim, Merck excluded from analysis anyone who “violated” the study protocol. In other words, all real-world problems that arose were excluded from analysis. Problems like girls who refused to take a second or third shot after they became sick and (correctly or incorrectly) blamed the vaccine. Or doctors who incorrectly gave the vaccine to someone who shouldn’t have received it. While it’s worth knowing how effective the vaccine is when it’s used exactly as it should be, for a public-health decision, it’s not as relevant as its real-world effectiveness.
To Merck’s credit, they reported that when all women in the study were analyzed, the vaccine’s efficacy dropped to 44 percent. Still, 44 percent might be considered a smashing success when you’re talking about saving lives. Except for one thing: the numbers get worse. The 44 percent benefit included only those women with the two specific cancer-causing HPV strains found in the vaccine. But when the researchers looked at negative cervical changes from any causes, they found that changes occurred in unvaccinated women at a rate of 1.5 events per 100 person-years, while vaccinated women had 1.3 events—dropping the benefit to 17 percent.
Moreover, most of the cervical changes tracked by the researchers weren’t even indicative of cervical cancer in the first place. Most were innocent cellular abnormalities that either disappear entirely on their own, or never progress to cancer. In fact, when they looked more closely at advanced cervical changes most likely to progress to cancer versus more innocent changes that go away spontaneously, it was the innocent changes that accounted for the decline.
Whether Gardasil will reduce cervical cancer deaths in real-world conditions has simply never been answered. It might—but that would take a long-term study, and one that should be done before it’s widely promoted.
A Cure in Need of a Disease
Now, come the boys. If cervical cancer prevention and gender equity don’t have you jumping out of your seat to grab every preteen boy to get a shot, what about the claim that Gardasil might prevent anal and oral cancers men may get from having sex with other men?
Merck says that in males, the vaccine is 89 percent effective against genital warts and 75 percent effective against anal cancer. On closer inspection, some of the numbers don’t just deflate, they evaporate. First off, let’s define the problem: The annual number of deaths from anal-rectal cancer among all men in the U.S. is 300. And how did Merck get its happy statistics on efficacy? Once again, they reported an idealized benefit by excluding from analysis 1,250 study violators out of 4,055 total test subjects. When the real-world analysis was conducted, the numbers plunged—right down to plum nothing. After evaluating tissue changes in male genitalia that were suggestive of a cancer precursor, Merck reported that vaccine efficacy against such lesions “was not observed.”
Given this, is it worth the risk of exposing millions of youth to the as yet uncertain harms of the vaccine? The CDC states that in rare instances, some vaccines may trigger the potentially fatal and paralyzing condition Guillain-Barré, and Nizar Souayah, MD, of the University of Medicine and Dentistry of New Jersey in Newark, says he and his colleagues found “clear evidence from our database of an increased incidence of Guillain-Barré syndrome in the first six weeks, especially the first two weeks, after [HPV] vaccination.” Guillain-Barré is very rare, even among people who are HPV vaccinated, but the problem is emblematic of the downsides of subjecting millions of people to any medical treatment.
Mo’ Money, Mo’ Money, Mo’ Money
So how did the HPV vaccine become a multi-billion-dollar winner for Merck? Well you might not be surprised to hear that the company happily lavished money on doctors, professional societies, and over 100 legislators. Of course, there is no tie between the recipients of this largesse and their promotion of the vaccine, say beneficiaries like presidential candidate and current Texas governor Rick Perry. In 2007, Perry signed an executive decree mandating that all girls in Texas receive the vaccine. The $28,500 Perry received was minor compared to his other connection to Merck: Perry’s chief of staff, Mike Toomey, became a lobbyist for Merck, championing the HPV vaccine. Once in that position, announced his plans to raise over $50 million for Perry’s presidential campaign.
In any case, the marketing certainly doesn’t seem to have hurt the adoption of Gardasil, which has been administered to millions of girls around the country. Caught up in the joy, some 41 state legislatures have initiated bills to promote or mandate the shots for all girls. With the CDC’s new recommendation for boys, one can imagine that promotion or mandates for them might come next.
Fortunately, some researchers don’t believe the hype. Dr. Diane Harper, one of the lead researchers in the development of the HPV vaccine, recently told the Kansas City Star, the vaccine for boys is “pie in the sky…We’re short of health care dollars. Why should we spend it on that?”
Indeed. There are better ways to spend the billions of dollars currently being spent on HPV vaccines. First, we already have a pretty terrific way to prevent most cervical cancer deaths, and it’s called the Pap smear. Since poor women are less likely to get Pap smears and more likely to die from cervical cancer, we could start by extending medical services to them. Second, many oral cancers are caused by smoking, and men and women who smoke are more likely to die of oral and cervical cancer, so we could invest in smoking cessation efforts.
As Angela Raffle, a specialist in cervical cancer screening, told the New York Times‘ Elisabeth Rosenthal, “Oh, dear. If we give it to boys, then all pretense of scientific worth and cost analysis goes out the window.”
Unfortunately, the hope that we would undertake low-tech, high-yield public health efforts might be the real pie in the sky thinking.
Full disclosure: I am not anti-vaccine. I’m happy to sport that little scar on my thigh from the smallpox vaccine I received as a kid. Smallpox is a scourge I can live without. Nor do I believe that every claim of calamity occurring after a vaccine is due to the vaccine. What I question is the promotion of vaccines, drugs and medical devices that aren’t backed up by solid clinical evidence and shown to be cost-effective in the real world.
Jeanne Lenzer is a medical investigative journalist and frequent contributor to the British medical journal BMJ. Her work has been published in The Atlantic, The New York Times Magazine, Newsweek Japan, and many other outlets.
* Fears over use of new cervical cancer vaccine
The One Click Group / Pamela McGowan, News & Star
* Gardasil vaccine: miracle or menace?
The One Click Group / Wish TV
* Class action on cancer vaccine Gardasil
Brigid O'Connell, Sunday Herald
* Art Caplan Challenged With Evidence of HPV Vaccine Harm
Vera Hassner Sharav, AHRP
Article provided by www.TheOneClickGroup.co.uk
To vaccinate or not to vaccinate? That is a question that continues to concern parents nationwide. And a new analysis found that, in eight US states, more than 1 in 20 public school kindergartners are not receiving all the vaccines required for school attendance. And in more than half of all states, there has also been a slight increase in the rate of exemptions over the past five years.
The issue has “really gotten much worse,” Mary Selecky, secretary of health for Washington state, tells the Associated Press, which conducted the analysis. In Washington, for instance, 6 percent of public school parents have opted out of vaccinations for their children. Rules for exemptions vary by state and can include medical, religious or - in some states - philosophical reasons, the AP notes (read here).
Health officials have not identified an exemption threshold that would likely lead to outbreaks, the AP writes, but there are concerns as exemption rates climb over 5 percent in some states. The average state exemption rate has been estimated at less than half that, although the AP adds that, in some rural counties in northeast Washington, rates are above 20 percent and even as high as 50 percent.
Why are rates climbing in some locales? There is ongoing concern that vaccine side effects can outweigh any benefits, a belief sparked by mistrust in government health officials and the medical community. A notable example was the recent scandal over research linking autism to vaccines, even though a new federal analysis maintained vaccines are safe for children (see here and here).
Such skepticism is fueled by the Internet and media reports, according to Amanda Dempsey, a pediatrician and researcher at the University of Michigan, who was lead author in a recent study that found up to 13 percent of parents of young children now use an alternative vaccination schedule. The study was published in Pediatrics (read the abstract).
“We are being told this by every government official, teacher, doctor that we need vaccines to keep us safe from these diseases. I simply don’t believe that to be true. I believe all the diseases in question were up to 90 percent in decline before mass vaccines ever were given. I don’t think vaccines are what saved the world from disease. I think effective sewer systems, nutrition, and handwashing (are the reasons),” Sabrina Paulick of Ashland, Orergon, a part-time caregiver for the elderly and a mother of a 4-year-old daughter, tells the Associated Press.
The issue of parent decision making also reflects the ongoing controversy over a Merck vaccine - the Gardasil shot used to prevent HPV, which can lead to cervical cancer. Earlier this year, the vaccine generated renewed controversy in California, where a law was passed that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. The California Catholic Conference sent notices warning parents that minors do not have adequate judgment about vaccination (read here).
For its review, the AP asked state health departments for kindergarten exemption rates for the 2006-2007 and 2010-2011 school years. The news service also examined data states had previously reported to the federal government, although most states do not yet have data for the current 2011-12 school year.
What did the AP find? Alaska had the highest exemption rate in 2010-11, at nearly 9 percent. The rate in Colorado was 7 percent, Minnesota 6.5 percent, Vermont and Washington 6 percent, and Oregon, Michigan and Illinois were close behind. However, childhood vaccination rates remain high overall, at 90 percent or better for several vaccines, including polio, measles, hepatitis B and chickenpox.
In many states, exemptions are filed for fewer than 1 percent of children entering school for the first time, the AP writes, adding that Mississippi was lowest, at essentially 0 percent. But the AP also found that vaccine exemptions rose in more than half of the states, and 10 states had increases over the five-year period of about 1.5 percentage points or more.
vaccine pic thx to lulu on flickr
There is so much written that is dead wrong about this year's flu vaccine, another post is needed. Here are some facts:
1. This year's flu vaccine is the same as last year's vaccine. If you are healthy and got the vaccine last year, you probably still have antibodies against all 3 strains.
2. The antigen used for the 2009 Swine Flu vaccine was an H1N1 hemagglutinen. It was used as a single antigen vaccine in 2009, but was included as one of the three hemagglutinin antigens in 2010 and 2011. In 2009, in some contries, a novel adjuvant was added to the antigen (either MF59 [Novartis] or ASO3 [Glaxo]) to increase the immune response.
In the US, for example, which used no adjuvant, the 2010 and 2011 flu vaccines contain the 2009 swine flu vaccine, plus two more antigens. Therefore, claims that this year the vaccine is entirely different are misleading.
In countries like Ireland and England, which used the ASO3 adjuvant in 2009, the current flu vaccine differs from 2009 because it has no ASO3. But it does have the same hemagglutinin adjuvant.
Narcolepsy cases have occurred after both adjuvanted and unadjuvanted swine flu vaccines were given.
3. How effective is the vaccine? Although 70-90% of recipients develop antibodies, the amount of flu that is prevented is questionable. Remember that studies from Hong Kong and Canada found that if you got flu vaccine in 2008, you were about twice as likely to become ill with a swine flu infection the next year? The effectiveness of the vaccine varies from year to year, but it is not very high, and never over 70% for the young and healthy. It is hard to show any efficacy in the aged.
4. The reason narcolepsy was discovered to be a side effect of swine flu vaccine in Finland was because there were 13 times as many cases appearing as usual. That is 1300% more cases than expected, of a very serious condition that can have lethal consequences.
5. Was narcolepsy the only serious adverse reaction to swine flu vaccine? It's unlikely.
You may have seen headlines that swine flu vaccine does not cause Guillain Barre Syndrome; I did, on the same day a report was issued about narcolepsy and the vaccine. However, It seems it DOES cause Guillain Barre Syndrome after all. The full text is here, or you can read the abstract below. CDC calculated it caused 1.77 times as many cases of GBS as expected, or 177%.
MMWR Morb Mortal Wkly Rep. 2010 Jun 4;59(21):657-61.
Dr Suzanne Humphries, MD
There is plenty of confusion on the topic of vaccination, especially amongst brainwashed doctors who trusted their medical schools. Then the unsuspecting, trusting public trusts them…because the medical establishment must know best, right? And doctors are nice people, trying to do a good thing. True. I was once one of those brainwashed doctors who believed in the benevolence of the medical system and believed that all I learned was the best that modern times had to offer. It is blazingly clear to me now though, that much of what is taught in medical school is enormously limited. I now see that most doctors are little more than blind slave-technicians who follow the dogma they were taught and were rewarded for repeating, even as the truth unfolds in front of them dictating otherwise.
Unbeknownst to most doctors, the polio-vaccine history involves a massive public health service makeover during an era when a live, deadly strain of poliovirus infected the Salk polio vaccines, and paralyzed hundreds of children and their contacts. These were the vaccines that were supposedly responsible for the decline in polio from 1955 to 1961!
But there is a more sinister reason for the “decline” in polio during those years; in 1955, a very creative re-definition of poliovirus infections was invented, to “cover” the fact that many cases of ”polio” paralysis had no poliovirus in their systems at all. While this protected the reputation of the Salk vaccine, it muddied the waters of history in a big way. Even during the peak epidemics, unifactorial poliovirus infection, resulting in long-term paralysis, was a low-incidence disease that was falsely represented as a rampant and violent crippler by Basil O’Connor’s “March Of Dimes” advertising campaigns. At the same time as Basil O’Connor was pulling in 45 million dollars a year to fund the Salk vaccine development, scientists started to realize that other viruses like Coxsackie, echo and enteroviruses, could also cause polio.
If you have doubts on the safety and effectiveness of vaccination, please keep your curiosity up, since the lives of your children may depend on it. You will probably have much deprogramming to do, just like most of us had.
Article provided by www.TheOneClickGroup.co.uk
The ongoing controversy over vaccine safety is taking a toll on the recommended vaccination schedule. As many as 13 percent of parents of young children now use an alternative schedule and, moreover, a large proportion of parents currently following the recommended routine seem to be “at risk” for switching to an alternative, according to a study in Pediatrics.
You may recall that, by age 6, children should have vaccinations against 14 diseases, in at least two dozen separate doses, according to federal government advisories. But even parents whose kids have adhered to the schedule are questioning federal health policy: 28 percent of those parents think delaying shots is safer than following the recommended schedule.
Of the 13 percent who now follow alternative schedules, 53 percent refused only certain vaccines and 55 percent reported delaying some vaccines until their child was older. Only 17 percent of that subset reported refusing any and all vaccines (read the abstract). But the results suggest more than 2 million infants and young children may not be fully protected against preventable diseases, the Associated Press writes.
However, the AP reminds us that recent data showed a record number of parents of kindergartners in California last year used a personal belief exemption to avoid vaccine requirements. And the Pediatrics survey of 748 parents mirrors a larger federal survey released last month showing at least one in 10 toddlers and preschoolers lagged on vaccines, including chickenpox and the measles-mumps-rubella combination shots.
One mom in Lakeville, Minnesota, is among those delaying vaccination for her kids. Kandace O’Neill tells the AP that her 5-year-old son has not been vaccinated since he turned 1, and her 7-month-old daughter has received none of the recommended shots. “I have to make sure that my child is healthy, and I do not want to put medications in my child that I think are going to harm them,” O’Neill tells the AP. She adds, by the way, that she is not against vaccination, but thinks that parents - not doctors or schools - should make medical decisions for their children.
Such skepticism is fueled by the Internet and media reports, according to Amanda Dempsey, the lead author of the study and a pediatrician and researcher at the University of Michigan. As an example, she points to the infamous debate over links between vaccines and autism, although a new federal analysis maintained vaccines are safe for children (see here and here). Dempsey, by the way, has been a paid adviser to Merck on issues regarding a vaccine for older children, but tells the AP the drugmaker did not contribute to the survey research.
The issue of parent decision making also reflects the ongoing controversy over a particular Merck vaccine - the Gardasil shot used to prevent HPV, which can lead to cervical cancer. In recent months, the vaccine has generated renewed controversy in California, for instance, where a bill would remove parental consent for vaccinating children 12 and older against sexually transmitted diseases. The California Catholic Conference, for instance, sent notices warning parents that minors do not have adequate judgment about vaccination (read here).
Various diseases that health experts say vaccines can prevent include flu and whooping cough, which can be deadly, especially in infants. Buddy Creech, an associate director of Vanderbilt University’s Vaccine Research Program, has two school-aged children who are fully vaccinated and a newborn who. he tells the AP, will be given all the recommended vaccinations. “From being someone in the trenches seeing children die every year from influenza and its complications…I would not do a single thing to risk the health of my kids,” he says. The AP notes that Creech has served on advisory boards for vaccine makers and received research grants.
Meanwhile, Larry Pickering, an infectious disease specialist at the Centers for Disease Control and Prevention, tells the AP that he supports the idea of parents being actively involved in medical care for their children, but cautioned that “if they’re going to do that, they need to be fully informed about the risks and benefits of vaccines and need to obtain the information from a valid source.”
vaccine pic thx to lulu on flickr
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