Marketing And Science Clash In Gardasil Debate : A Cure in Need of a Disease : Merck… Mo’ Money, Mo’ Money, Mo’ Money
Gardasil, Merck’s vaccine against the human papilloma virus, the most common sexually transmitted disease, is once again at the centre of political, moral, bioethical and economic controversy after last month’s recommendation by the Centres for Disease Prevention and Control (CDC) that 11 and 12-year-old boys be vaccinated.
The CDC recommended in 2006 that that girls and young women between 11 to 26 should be vaccinated. Not all parents were happy. Some thought that protecting their daughters against HPV, the most common cause of cervical cancer, was common sense. Others thought that it would encourage promiscuity. The controversy infected Republican campaigns for the presidential nomination. Foes of Texas governor Rick Perry pointed out that he backed universal vaccination although it failed in the state legislature. Michele Bachman was ridiculed for asserting that Gardasil caused mental retardation.
The controversy is back on the boil. Although the main benefit is that vaccinated boys will be less likely to spread HPV to girls and thus promotes gender equity, it also is said to prevent oral and anal cancers associated with oral and anal sex. Parents are even less likely to support a vaccine which assumes that their sons will engage in homosexual activity.
This week science journalist Jeanne Lenzer criticised the vaccine in the on-line magazine Discover. Her complaint was economic, not moral. Merck is promising far more than its vaccine can deliver, she feels, and questions the real-world efficacy of the vaccine in preventing deaths from cervical cancer. “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.”
Similarly, she contends, assertions that the vaccine prevents oral and anal cancers in men who have sex with men are weak. “On closer inspection, some of the numbers don’t just deflate, they evaporate,” she says. On the other hand, “in rare instances, some vaccines may trigger the potentially fatal and paralyzing condition Guillain-Barré.”
Given the risks, is a Gardasil campaign worthwhile? She quotes Dr. Diane Harper, who helped to develop the HPV vaccine. She told the Kansas City Star that the vaccine for boys is “pie in the sky…We’re short of health care dollars. Why should we spend it on that?”
This is a controversy which still has plenty of life in it: politics, vaccine phobias, cost controls, the evils of Big Pharma, the culture wars, sexual politics. Stay tuned!
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 donebefore 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.
Post-Gardasil Syndrome - The New Name For The Spectrum Of Side Effects Following HPV Vaccination
Wednesday, December 07, 2011 by: Rosemary Mathis, Vice President of Victim Support, SANE VAX,
(NaturalNews) 2007 Ohio: 21 year old college student, Brittney (http://sanevax.org/brittany-from-ohio/), was told by her family doctor she needed the Gardasil vaccine to protect her from getting an HPV (human papillomavirus) infection via an accident at her college lab. Afraid that the doctor may be right and after being assured there were no risks involved, she consented to vaccination with Gardasil. New medical conditions began to appear almost immediately. After the second dose, Brittney lost the use of her legs. Four years and more than 40 medical specialists later, she has still not recovered from the extensive list of 'new medical conditions' aka adverse events she began to experience after Gardasil. She still suffers from PGS (Post-Gardasil Syndrome).
2010 California: A mother takes her 13 year old daughter for a routine check-up. When the doctor is informed that they have decided Gardasil is not right for her, the doctor asks to speak with the child alone. After taking the girl into a private room, she is told horror stories about cervical cancer from HPV and informed that she can have the vaccine right now and doesn't even have to tell her mother. The girl still refuses. The pediatrician then escorts mom and daughter to the waiting room and announces loudly that "Your refusal to take Gardasil puts you at risk of getting cancer and dying should you be raped."
2011 Canada: A 13-year old girl presents a signed vaccine waiver form for Gardasil to her school nurse. Camille's mother had even gone so far as to call the school on the morning Gardasil injections were scheduled to make sure there would be no problem with their decision to refuse this particular vaccine. Two school nurses spend a total of 25 minutes threatening, cajoling and intimidating Camille (http://sanevax.org/victim-of-post-g...) until she finally gave in and consented to the injection. She was told not to show her mother the vaccination record. Barely two hours later, she was admitted to the hospital - another victim of Post-Gardasil Syndrome suffering fever, rash, fainting, fatigue, weakness, headaches, stomach pains, urinary infection, and abscesses in her mouth, vision impairment and oral Candida.
February 2011, Tennessee: Wendy's daughter had been ill. After a couple of weeks, when she was still not feeling quite normal, Wendy decided to take her to the pediatrician for a check-up. The doctor walked in the examining room, looked at the girl's medical chart, and said she needs her chicken pox vaccination. Wendy informed him that she had already had her chicken pox vaccine. Doctor explained that it was time for a booster, so she agreed.
Then the pediatrician informs Wendy that her daughter will be receiving four shots that day - chicken pox, hepatitis A, meningitis and Gardasil. Wendy had no objections to the first three, but she had done some research on Gardasil and decided this particular vaccine was right for her daughter. She told the doctor that under no circumstances was her daughter going to get Gardasil.
The doctor proceeded to argue with her, trying very hard to convince her to allow her daughter to get the shot. He went so far as to present arguments like, "What if she is raped? You can drive a car with no insurance, but if you get in an accident - you're done." Wendy held her ground - the doctor threw up his arms and left. All of this time, he never inquired about the girl's illness.
Enter the nurse, with four syringes instead of three. When Wendy informs her that the Gardasil will not be injected, the nurse sternly replies, "Well, he wrote it down and I am giving it to her!" A brief shouting match later, Wendy and her daughter leave the pediatrician's office - without the Gardasil injection.
Consider the serious adverse reactions reported after Gardasil injections. Steven Rubin posted disturbing data on the MedAlerts Blog (http://medalerts.org/analysis/archi...), sponsored by NVIC, regarding reports filed with VAERS. Refer to the chart in the blog for reference.
Number of Serious Events Reported to VAERS by Disease:
The chart clearly illustrates serious HPV vaccine injury reports filed were more than double the number of similar events reported for other 'CDC-recommended vaccines' administered in the 7-18 age group despite the fact that Gardasil is not yet the most widely used vaccine in that cohort.
Any VAERS report that indicates hospitalization, permanent disability, life-threatening illness, congenital anomaly or death is classified as serious.
Of the 75 FDA-approved vaccines, two HPV vaccines account for 16% of the entire VAERS database. What is wrong with this picture?
In the United Kingdom, according to Anne Milton (UK Health Minister), one out of every six adverse reactions reported after Cervarix is considered serious. PCS (Post-Cervarix Syndrome) is becoming all too prevalent in their teen population.
PGS (Post-Gardasil Syndrome) is being experienced around the world. Thousands of parents (acceptable collateral damage?) are left trying to put the pieces of their child's former life back together, or worse - trying to put their own lives together without the children who were once there.
Still, in the face of all evidence to the contrary, medical professionals and health authorities continue to push so-called 'safe and effective' HPV vaccines on their innocent, uninformed patients. Does pediatric pressure promote PGS/PCS? Research, look at the evidence and then decide.
Medical consumers are banding together world-wide to inform themselves. They are examining the hard scientific data, consulting experts and determining what is best for their own health.
Most importantly, victims of PGS/PCS are shouting their stories from the rooftops. Families are telling the world in no uncertain terms their children are real people - not statistics, and certainly not acceptable collateral damage in a mass medical covert experiment to determine whether or not HPV vaccines have any impact on cancer fifteen to twenty years down the road.
Medical consumers are no longer willing to accept a 'poke and hope' proposition with their children being used as the guinea pigs. It is time for the medical community to wake up and pay attention to the science. It is time for government health officials to do the job they are paid to do. It is time for governments to get out of the vaccine business and start protecting their constituents' health and safety.
It is long past time for independent, well designed studies on HPV vaccine safety, efficacy, and need. Medical consumers will accept nothing less.
[Note: If you, or a friend, suffer from PGS/PCS, please contact us at email@example.com, we will be happy to help you be a part of the solution by telling your story.]
By Norma Erickson, President of SaneVax Inc. (http://sanevax.org/).
About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.
Articles on this site are written by Norma Erickson, President and Leslie Carol Botha, women's health educator, broadcast journalist and Vice-President Public Relations for SANE Vax, Inc. We also allow content from various contributing authors. Other members include Rosemary Mathis, mother of a Gardasil-injured daughter and Vice President Victim Support; Janny Stokvis, Vice-President Research, Freda Birrell, Secretary and HPV vaccine lobbyist United Kingdom /Scotland, and Linda Thompson, Treasurer.
We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.
SANE Vax, Inc. is involved in the ground-breaking production of the One More Girl Documentary which will premier in 2012. Please join our cause by contributing to this project by contacting Ryan Richardson, Producer at firstname.lastname@example.org.
For more information, please visit our site athttp://sanevax.org/.
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