It's been four years since Gardasil debuted as a blockbuster vaccine with sales that rocketed to over $1.1 billion in its first nine months.
Touted as a wonder vaccine that would end cervical cancer, it was supposed to be the savior of both mankind and Merck's Vioxx-damaged bottom line. But now, according to CNN Money, it's a dud.
It just posted $219 million in sales. But in the pharma world, that's a paltry pittance, nothing short of an in-flight explosion that's caused Merck stock to drop 3 percent, with analysts and investors scrambling to figure out what went wrong.
So what happened?
How did a vaccine that was supposed to be Merck's beacon for higher profits in the 21st Century go from flagship to flop?
The Science Speaks for Itself
CNN Money calls Gardasil's crash a "design flaw" and faults the economy, puritanical parents, bad press, and Merck itself for contributing to the fallout.
The article ends with the hypothesis: "Or, maybe people just aren't ready for a cancer vaccine when it's for a sexually transmitted disease."
I think they're way off the mark.
The real reason Gardasil is a flop is that people have become educated about this vaccine.
They've looked at the science and weighed the risks vs. the supposed benefits, and have made a choice not to get it for themselves or their children.
The word is out: despite what the CDC would have you believe, Gardasil's safety record is in serious question. As of September 28, 2010, the Vaccine Adverse Events Reporting System (VAERS) has more than 18,000 Gardasil-related adverse events listed in it, including at least 65 deaths.
As a vaccine used in the developed world, the science speaks for itself: Gardasil can't – and never will -- replace Pap smears, which are the reason that the incidence of cervical cancer is so low in the United States after decades of including pap smears in routine medical care for women.
Today, cervical cancer is not even in the top 10 cancers that kill American women every year.
As a vaccine for children, it doesn't make sense to vaccinate to try to prevent an infection that is cleared from your body without any negative effects within two years in most healthy persons, and is not transmitted in a school setting like other airborne diseases that are easily transmitted in crowded conditions.
Gardasil is designed to prevent only two of at least 15 strains of HPV that can lead to cervical cancer in those who do not clear the virus from their body within two years and become chronically infected.
There is also some evidence that Gardasil-induced immunity may wane after about five years. Pre-licensure clinical trials did not follow young girls or women for decades to find out if the vaccine does, in fact, prevent cervical cancer.
What went wrong with Gardasil is that this may be a vaccine that set many more health care consumers on a course of self-education that helped them make an informed decision about whether or not to take it – and there are several good reasons why many are deciding NOT to take it.
Science vs. Politics
First, the science: Peer-reviewed journal articles widely available on the Internet show that Gardasil is not what it was made out to be in the "one-less" TV commercials that jumped into people's living rooms a few years ago.
Consumers now know that:
- Gardasil is NOT a cancer vaccine. It is simply a vaccine for two strains of human papillomaviruses (HPVs) that in some instances can lead to cancer in some women (Gardasil's other two HPV strains are for genital warts, which don't cause cancer).
- Since there are at least 15 HPV strains that can lead to cancer, Gardasil-vaccinated girls can still get cervical cancer from other 13 HPV strains not contained in the vaccine.
- The vaccine doesn't work if you've already been infected with the HPV strains in the vaccine.
However, the real truth is that Gardasil's downfall has nothing to do with sex or money.
The Truth about HPV and Cancer
It is important to distinguish between HPV and cancer: Just because you currently have HPV, or may have had the infection in the past, does NOT mean you have cancer or will get cancer.
HPV is NOT cancer. It is a viral infection that can lead to cancer in some people if the virus does not naturally clear from your body, as it does for most people within two years.
Some high risk factors for developing chronic HPV infection are:
- Co-infection with herpes, Chlamydia or HIV
- Long term birth control use
- Multiple births
The important thing to know about HPV is that in almost all cases, it clears up on its own without any adverse health effects within two years in most healthy people.
Genital HPV infection that is persistent, and more likely to lead to cancer, is most common in men and women who have had multiple sex partners. According to the CDC, other contributing risk factors to HPV infection that leads to cervical cancer includes smoking, having herpes, Chlamydia or HIV (the virus associated with AIDS), or another health problem that makes it hard for your body to deal with infections.
Using birth control pills for a long time (five or more years) or having given birth to three or more children is also a risk factor.
Also, certain populations in the US are more prone to getting cervical cancer. According to CervicalCancerCampaign.org:
"Cervical cancer occurs most often in certain groups of women in the United States including African-American women, Hispanic women, white (non-Hispanic) women living in rural New York State and northern New England, American Indian women, and Vietnamese-American women.
Hispanic women have twice the rate of cervical cancer compared to non-Hispanic white women. African-American women develop this cancer about 50 percent more than non-Hispanic white women".
These disparities are due, in part, from poor access to health care. The women who are most at risk for the disease are women who do not have regular check-ups that include pap tests.
Official reports from the CDC and WHO estimate that between 11,000 and 12,000 women in the US are diagnosed with cervical cancer each year, and 3,800 to 4,100 die from it.
About half of these women had never had a pap smear before they discovered they had cervical cancer. The majority of the others had not had a pap smear within the previous five years.
According to the CDC's report on HPV to Congress in 2004:
"Cervical cancer is an uncommon consequence of HPV infection in women, especially if they are screened for cancer regularly with pap tests and have appropriate follow-up of abnormalities.
The purpose of screening with the pap test is to detect cervical abnormalities that can be treated, thereby preventing progression to invasive cervical cancer, and also to detect invasive cervical cancer at a very early stage. If detected early and managed promptly, survival rates for cervical cancer are over 90 percent."
A study published in 2000 in the Archives of Family Medicine also showed that in the US, women who are elderly, unmarried, and uninsured are more likely to be diagnosed at a late stage of cervical cancer.
The Truth About Gardasil
According to a 2006 report to the international group Program for Appropriate Technology in Health (PATH), Gardasil and Cervarix (GlaxoSmithKline's two-strain HPV vaccine) are only effective in young women and men (boys are now approved to receive HPV vaccine) who have never been infected with HPV.
According to Merck's package insert on Gardasil, the end-point in its clinical trials for the vaccine's efficacy, or effectiveness, was NOT cancer, but instead was the presence, or non-presence, of vaccine-relevant pre-cancerous lesions (CIN 2/3).
There is absolutely no proof, and no clinical trials that show Gardasil protects against cancer in the long-term.
In fact, in clinical trials, Gardasil's protection against cell dysplasia leveled off at four years, and clinical trial participants were given a fourth dose to boost the number of antibodies measured in the blood (immunogenicity) of those who got the vaccine. This is the efficacy being reported by Merck, even though the vaccine series is marketed as three shots, not four.
And, according to Dr. Diane Harper, a lead researcher for Gardasil, its efficacy against genital warts is only two years.
Additionally, according to the manufacturer's package insert:
- Gardasil does not eliminate the necessity for pap screening
- It does not treat active infections, lesions or cancers
- And it may not result in protection for all vaccinees
An outstanding question is whether the mass use of Gardasil (and Cervarix) by all girls and boys will put pressure on other HPV strains not contained in the vaccines to become more dominant and perhaps more virulent in causing cervical cancer.
The "replacement" effect has happened with other infectious organisms that have developed resistance to vaccines used on a mass basis, such as pertussis (whooping cough) and pneumococcal vaccines.
The Truth about Gardasil's Clinical Trials
Only 27 percent of girls who have received the Gardasil vaccine have gotten all three shots in the vaccine's series. Merck blames it on forgetfulness, and has launched a "reminder" program that contacts vaccinees, and urges them to complete the series.
CNN Money suggests that it has to do with the vaccine's high cost – just under $400 for a three-shot series, although some private doctors charge up to $875 for a three-shot series.
But neither has considered the third possibility – that the reported reactions girls are suffering after getting one or two shots of Gardasil are so severe that they decide not to go back for more.
In any drug trial, whether it's for a vaccine or not, safety should be the top priority – and Gardasil's safety should have been thoroughly investigated before it was licensed and put on the market and recommended by public health doctors for ALL young girls to use.
But Merck used bad methodology in its pre-licensure safety studies that did NOT contain a true placebo. In reporting systemic adverse reactions to the vaccine, instead of using a true placebo that is not reactive on its own, Merck used a vaccine component (aluminum) in what they called the "placebo."
Aluminum can cause inflammation in the body and can make your blood brain barrier more permeable, allowing toxins to pass into your brain and cause damage. It is definitely not appropriate to use an aluminum-containing "placebo" to measure the reactivity of an experimental vaccine like Gardasil that will be given to children.
Researchers did use a saline placebo in one clinical trial, but only reported it in reference to injection site reactions. In those comparisons, the saline placebo had significantly fewer reactions than either the vaccine or the aluminum-containing placebo.
When it came to reporting the actual adverse, systemic events with the vaccine, Merck combined the aluminum and saline placebos, thus making the "placebo" results nearly the same as the vaccine's – and impossible to objectively judge true safety comparisons.
This encouraged the perception that the vaccine is "safe" because the adverse events associated with it were nearly the same as the aluminum containing " placebo."
Another important outcome of the clinical trials that was not properly investigated before licensure was the potential association between the deaths that occurred in the clinical trials and the Gardasil vaccine.
A number of the girls who died during the trials were killed in car crashes. Yet, Merck did not report whether the girls were the drivers or passengers at the time of the accidents.
This could be critical information in determining the vaccine's true safety, since one of the most common post-marketing adverse events is syncope (sudden fainting) as well as dizziness, seizures, and neurological events that could have contributed to a car accident if the person had just received a Gardasil shot and was driving at the time of the accident.
The Truth about Gardasil and its Thousands of Injuries and Deaths
The federal Vaccine Adverse Events Reporting System (VAERS) has been in place since 1986, but many experts believe that only 1 to 10 percent of all serious health problems that occur after vaccination, including hospitalizations, injuries and deaths, ever make it into the VAERS database.
Most doctors and other vaccine providers do not report vaccine-related adverse events to VAERS even though it is a requirement under federal law since 1986 with the passage of the National Childhood Vaccine Injury Act.
Gardasil was a "fast tracked" vaccine and with so little active reporting of Gardasil-related health problems to VAERS, this means that Gardasil should be on the red-alert list for agencies like the CDC, the FDA, and the Advisory Committee on Immunization Practices (ACIP).
Yet these three federal health agencies and medical organizations urging doctors to give Gardasil to children and young women have joined Merck in insisting that Gardasil is safe, despite mounting evidence to the contrary.
Gardasil victims and their parents have been posting their heart breaking stories on websites.
These tragic entries posted by Gardasil casualties is stark testify to the fact that something isn't right with this vaccine – and what isn't right is that the list of Gardasil victims just keeps growing.
The unfortunate fact is Merck only studied the vaccine in fewer than 1200 girls under age 16, and most of the serious health problems and deaths in the pre-licensure clinical trials were written off as a "coincidence."
And now, since those adverse reactions aren't listed as possible warning signs that the vaccine can cause harm, health officials are still ignoring them, even while girls die and others suffer ongoing, and often permanent, injuries and disabilities from it.
For example, a rough comparison of Gardasil and Menactra (a vaccine against meningitis) adverse event reports to VAERS through November 30, 2008 revealed that:
- Compared to Menactra, receipt of Gardasil is associated with at least twice as many emergency room visit reports; 4 times more death reports; 5 times more "did not recover" reports; and 7 times more "disabled" reports.
- Compared to Menactra, receipt of Gardasil is associated with all of the reports of blood clots. All 23 reports of blood clots following Gardasil occurred when Gardasil was given alone without any other vaccines.
- Compared to Menactra, receipt of Gardasil is associated with at least 4 times as many cardiac arrest reports. All 9 reports of cardiac arrest following Gardasil occurred when Gardasil was given alone without any other vaccines.
- Compared to Menactra, receipt of Gardasil is associated with at least 6 times as many fainting reports and at least 3 times as many syncope reports.
- Compared to Menactra, receipt of Gardasil is associated with at least 4 times as many lupus reports. 27 reports of lupus following Gardasil occurred when Gardasil was given alone.
- Compared to Menactra, receipt of Gardasil is associated with at least 15 times as many stroke reports. 16 reports of stroke following Gardasil occurred when Gardasil was given alone.
- Compared to Menactra, receipt of Gardasil is associated with at least 3 times as many syncope reports.
- Compared to Menactra, receipt of Gardasil is associated with at least 33 times as many thrombosis reports. 34 reports of thrombosis following Gardasil occurred when Gardasil was given alone.
- Compared to Menactra, receipt of Gardasil is associated with at least 5 times as many sasculitis reports. 11 reports of vasculitis following Gardasil occurred when Gardasiil was given alone.
- Compared to Menactra, receipt of Gardasil is associated with at least 30 times as many rechallenge reports, which involve a worsening of symptoms experienced after previous receipt of Gardasil.
What's disturbing about this is that these reports in all likelihood are just the tip of the iceberg because most physicians are making their reports to Merck, rather than to VAERS, and Merck is forwarding such poor quality information to VAERS that the CDC and FDA can't follow up on the majority of reports that Merck makes.
As reported in the Journal of the American Medical Association in August 2009, Merck made 68 percent of the reports to VAERS and 89 percent of them had information that was too insufficient to review!
Is This a Vaccine that You Would Want?
An editorial in the August 19, 2009 issue of the Journal of the American Medical Association (JAMA) commented specifically on the risks and benefits of vaccinating with Gardasil, Merck's marketing of it, and the safety issues that are so obvious with this drug:
"When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit," the JAMA author said.
"Patients and the public logically expect that only medical and scientific evidence is put on 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."
The commentary is so poignant that it's a wonder that the mainstream media still hasn't' picked up on the impact of what this author is trying to say – that maybe, just maybe, people shouldn't be so quick to jump on the Gardasil bandwagon.
The JAMA commentary goes on to say that one of the core questions of all medical decisions should be: When is the available information about harmful adverse effects sufficient to conclude that the risks outweigh the potential benefits?
It's apparent that that question is in the minds of anyone who has really taken the time to study this vaccine.
What happened to Gardasil is that consumers looked at the science and lots of them made a choice to not use this vaccine.
And that, CNN Money, is why Gardasil is a flop.