For instance, after just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family filed a petition for vaccine compensation seeking damages from the government.
A group of Australian researchers found young women there who received the drug t were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women overseas died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered.
A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of a degenerative muscle disease after her third Gardasil injection; she is almost completely paralyzed.
Now, the Rocky Mountain News is reporting about a 16-year-old girl who is sick all the time with constant exhaustion and nausea; hair falling out in clumps, ongoing episodes of passing out, numbness, and paralysis; dangerously low blood pressure; and severe back spasms that cause her to stop breathing. The family is convinced the reactions are a result of Gardasil vaccinations, which in her case, were given with a meningitis vaccine.
Although industry claims the Gardasil-meningitis combination is safe, and although the combination is routinely administered, Rocky Mountain News points out that Gardasil has never been clinically tested in this combination. As a matter-of-fact, the meningitis vaccine was not available when clinical testing for Gardasil was first being conducted, so the U.S. Food and Drug Administration (FDA) agreed to test it after licensure was granted said Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. Those clinical results remain pending.
Worse, says Rocky Mountain News, according to the National Vaccine Information Center, Gardasil reactions increase when given with the meningitis vaccine. Also, Halsey reported that general guidelines allow for two or three inactivated vaccines—and Gardasil and the meningitis vaccinations fall into this category—to be administered conjunctively without an expectation of increased adverse events.
Merck and Co.'s Gardasil was licensed in 2006 by the FDA and both the Centers for Disease Control and Prevention (CDC) and Merck say it is safe; however, as of late summer, the federal Vaccine Adverse Event Reporting System (VAERS) logged 10,326 reports of reactions to Gardasil, according to the CDC, including reports of Guillain-Barre syndrome, a rare disorder that causes muscle weakness, blood clots, and death.
Gardasil accounted for about 20 percent of reactions reported to VAERS in 2007-2008 according to Barbara Loe Fisher, co- founder and president of the National Vaccine Information Center. “To say that … 10,000 reports of reactions, injuries, 30 deaths is all a coincidence is simply not scientifically responsible," Fisher told the Rocky Mountain News. "You have perfectly healthy girls go in and get this shot and then suffer a pattern, a very clear pattern of injury, and some of them are dying. This is not acceptable." Side effects reported involve brain inflammation; immune system dysfunction; tingling and numbness in the hands, feet and legs; severe headaches; strokes; joint pain; muscle weakness; seizures; and memory loss Fisher said.
The Vue Weekly points out that many believe over-immunization is a major contributor to the rise in autoimmune disease and parents are often pressured to immunize. But, in the case of Gardasil, perhaps avoiding the vaccine might not be so irresponsible given that, as The Vue pointed out, “the research was done by those who stand to gain magnificently” and the drug has been the focus of “an extensive public relations campaign” but “has been subjected to little independent scientific review.”
Of note, the Vue points out that the Nobel Prize Committee—which awarded the 2008 Nobel Prize in Medicine to German scientist Harald zur Hauser for his work linking HPV to cervical cancer—is facing investigation over bribery allegations for taking payments from the drug company that own the patents and collects royalties on both—U.S. and overseas—HPV vaccines. Also, said the Vue, an FDA document stated that, “identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting. It is the persistent HPV infection that may act as a tumor promoter in cancer induction ... most infections are short-lived and not associated with cervical cancer.” Perhaps the vaccine is not so critical after-all.
Gardasil was approved by the FDA in June 2006, at which time Merck said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly thereafter, the U.S. Centers for Disease Control and Prevention (CDC) issued a recommendation that all young girls age of 11 and 12 receive the Gardasil vaccine. Meanwhile, there have been 9,749 adverse reactions and 21 reported deaths since 2006 in young girls following Gardasil vaccination with side effects that included 10 miscarriages, 78 severe outbreaks of genital warts, and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS). Gardasil is approved for females age nine to 26.
Now, the FDA is looking for additional information from a four-year study of Gardasil’s safety and effectiveness before considering its approval for the drug for women ages 27 to 45, reports Bloomberg. The FDA delayed an earlier request for Gardasil to be approved for use in older women following an expedited review of the drug.
In Western countries like the U.S., regular Pap test screening has greatly reduced the incidence of cervical cancer and death; however, even after vaccination, regular Pap tests are needed since Gardasil does not protect against all HPV strains known to cause the cancer. According to Tim Anderson, an analyst at Sanford Bernstein & Company, “Gardasil’s efficacy drops sharply once females have been exposed to HPV, and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application,” reports Bloomberg.
Anderson said that this second FDA rejection presents, “yet another setback” for Merck; Gardasil is “one of Merck’s key products,” he added, noting 1.5 billion in sales in 2007, according to Bloomberg, which also noted that sales have dropped in the past two years following questions regarding Gardasil’s “cost, safety, and” efficacy. Merck stocks have fallen 53 percent in the past 12 months, said Bloomberg, which added that Merck is hoping Gardasil will enable the company to recoup some of its lowered profits due to Vytorin, Zetia, and Singulair woes. The vaccine costs about $400 to administer.
Merck plans on responding to the agency by this year’s fourth quarter, said Bloomberg, which explained that this follows Merck’s response to the FDA this summer following the FDA’s first request.
Last month, Merck applied to the FDA for approval to sell Gardasil for men claiming a 90 percent reduction in risk of genital warts and pre-cancerous lesions.
Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the U.S. Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
But not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
Other questions have been raised about the cost effectiveness of HPV vaccines like Gardasil. Those concerns were explored by an article in the New England Journal of Medicine this past August. The article detailed a analysis done by Harvard researchers on the cost effectiveness of Gardasil, and another HPV vaccine called Cevarix. Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.
To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life
The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That’s because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.
In Western countries like the U.S., regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don’t protect against all HPV strains known to cause the cancer.
Despite questions surrounding its safety and cost-effectiveness, Merck still wants the uses of Gardasil expanded. According to The Wall Street Journal, Gardasil is a key product for Merck, which estimates sales this year of as much as $1.6 billion. But sales have slowed, down 4% in the third quarter compared to a year earlier. Merck's crusade for expanded approval may be part of a strategy to lift these sagging sales.
In the Journal of Law, Medicine & Ethics, three academics—Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine, and Lawrence Gostin of Georgetown University Law Center—contend state and local governments should not require girls receive Gardasil vaccinations. The three cite public health and constitutional reasons saying that Gardasil does not address the same level of public health threat as existing mandates for polio, measles, and other childhood vaccinations. Because of this, they note, courts will likely not uphold the constitutionality of a mandate for vaccination against HPV. “We should be careful about adding more and more vaccine requirements when they exceed the original purpose of mandatory, school-based vaccinations,” Javitt said, recommending instead that states educate parents about the benefits “because it will allow parents to make informed decisions without coercing them.”
Controversy over Merck’s lobbying of states to require vaccination led it to cease those attempts and prompted governments to lean more toward education and funding efforts. Merck spokeswoman Amy Rose announced that Merck stopped lobbying for Gardasil school-requirements and is focused on educating policy and lawmakers looking at Gardasil use about HPV, cervical cancer, and the vaccine. “Merck’s goal is to ensure that Gardasil … is used to its fullest appropriate extent to help reduce the burden of cervical cancer and other HPV-related diseases in the United States,” Rose wrote.
Gardasil was sped through US Food and Drug Administration (FDA) approval after a brief six-month period. Critics, including scientists, have long wondered if Gardasil’s benefits are outweighed by its serious and sometimes fatal risks, saying it is only modestly effective and its safety has not been adequately proved. After just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, has spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family just filed a petition for vaccine compensation seeking damages from the government. A group of Australian researchers found that young women there who received Gardasil were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women oversees died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of having been stricken with a degenerative muscle disease after her third Gardasil injection; she is now almost completely paralyzed.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
Gardasil may also cause more allergic reactions than other vaccines. Last month, Australian researchers at the Children’s Hospital at Westmead are reported that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.
Side-effect concerns are taking their toll, and many parents don't want their young daughters exposed to such a questionable vaccine. According to Bloomberg.com, US sales of Gardasil dropped by 33 percent this past summer. Since then, Merck shifted its marketing efforts to older women. To reach the older age group, Bloomberg.com reports that Merck is advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has also been selling $32 cervical-cancer awareness charm bracelets on the Internet. And, Merck is seeking FDA approval to market Gardasil to women through age 45.
But Merck's latest Gardasil marketing efforts are being questioned on some fronts, as it is unclear how much older women would benefit from the vaccine. In August, a study in the New England Journal of Medicine questioned the cost effectiveness of such an approach. A treatment is typically considered cost effective if it costs health systems less than $50,000 or $100,000 for one additional year of life. The analysis, conducted by Harvard researchers, predicted that it would cost $43,600 to extend life expectancy by one year when girls are vaccinated at 12. But when girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26.
The American Cancer Society is on record as recommending that Gardasil vaccination efforts focus on younger girls. ``The push needs to be with the 11- to 12-year-olds,'' Debbie Saslow, director of breast and cervical cancer for the American Cancer Society, told Bloomberg.com. ``It is not going to be as effective in the older women.''
But Merck is not really interested in how effective Gardasil might be for women in the older age group. Faced with declining sales of other drugs in its product line - specifically Vytorin and Zetia - and questions about the safety of the asthma drug Singulair, its top-selling product, Merck desperately needs to prop up Gardasil sales.
Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. "For a new vaccine, 25 percent is really very good," Lance Rodewald, director of the division of immunization services at the Centers for Disease Control and Prevention (CDC) said. "We need to see that rate every year if we are going to meet our goal" of having 90 percent of teenagers vaccinated, he added. But immunologist W. Martin Kast, of the University of Southern California's Keck School of Medicine, said, "Twenty-five percent is not bad, but it's not good either." Last May, the U.S. Centers for Disease Control and Prevention (CDC) said Gardasil is linked with a higher risk of fainting.
The vaccine has been criticized by scientists who say it is only modestly effective and its safety has not been adequately proved; conservative groups who say that giving it to young girls implies approval of sexual activity; and consumer advocates who say its price, $360 for a series of three shots, is prohibitive. Meanwhile, we reported on a group of Australian researchers who found that young women there who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs.
In July, Gardasil was criticized for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection. In June, Merck added more possible adverse reactions to Gardasil’s growing list, including fatigue, weakness, and muscle pain. Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Recently, a 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.
U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.
The U.S. Citizenship and Immigration Services added the Gardasil vaccination requirement in July, and it went into effect on August 1. Under a 1996 immigration law, any vaccination recommended by the U.S. government for its citizens becomes a requirement for anyone seeking permanent residency in the U.S. The Centers for Disease Control recommended Gardasil for girls ages 11 through 26 shortly after it was approved in 2006.
Anyone who applies for permanent residency must visit a U.S. - approved physician or clinic to get vaccines and undergo tests in order to receive health clearance. Of the 14 required vaccines, 13 are designed to combat infectious diseases that are transmitted by respiratory route and are considered highly contagious. But the virus Gardasil targets – HPV – is spread through sexual contact.
One public health expert told The Wall Street Journal that the Gardasil rule is not needed because of the way HPV is spread. "We don't want someone coming into the U.S. who hasn't been vaccinated against measles or chickenpox," said Dr. Abramson, chairman of the department of pediatrics at Wake Forest University School of Medicine in Winston-Salem, N.C. "HPV can only be communicated by sexual contact....This is not something that endangers kids in a school setting or puts your population at risk."
Some immigrant advocates see the Gardasil rule as a ploy to discourage legal immigration by making the process more expensive. The 3-shot Gardasil series can cost between $300 and $1,400. "What we have noticed is that applying for citizenship decreases as the fees go up," Ana Correa, executive director of the Texas Criminal Justice Coalition, told the Dallas Morning News. "I don't think it's a coincidence that they're pushing for a policy that would provide a burden on immigrants."
Others complain that the safety of Gardasil still has not been established. "Given the controversy over the vaccine's effectiveness and adverse side effects, mandating the vaccine for immigrant women is premature and is arguably equivalent to using them as test subjects," Priscilla Huang, policy and program director at the National Association of Pacific American Women's Forum, told The Wall Street Journal
Officials at the CDC say that the agency’s Gardasil recommendation was not meant to make the Gardasil vaccine mandatory for immigrants. A CDC spokesperson told The Wall Street Journal that the vaccination committee did not realized the way its Gardasil recommendation would impact immigrants.
Gardasil maker Merck & Co. – which has been aggressively lobbying states to make the vaccine mandatory for young girls - claims it had nothing to do with the immigration rule. "We were not aware of the policy and we did not lobby for this provision in any way,” a Merck spokesperson said in a statement to the Journal. However, the statement said that Merck would not engage in any efforts to address the new immigration requirement.
The U.S. Citizenship and Naturalization Service added the HPV vaccination requirement in July, when it revised the Centers for Diseases Control's (CDC) Technical Instructions to Civil Surgeons for Vaccination Requirements. The Service is also requiring immigrants applying for citizenship to be vaccinated against hepatitis A, rotavirus, meningitis and chicken pox. But those are highly contagious disease, while HPV is not.
The new regulation is causing quite a bit of controversy because current U.S citizens are not required to have the Gardasil vaccine. "If the government is trying to take care of everyone, they should be doing it also with the citizens," Ginky-Lee Torres, an immigration lawyer, told a North Carolina TV station.
Even the CDC - which recommends Gardasil for girl and women ages 11 to 26 - has not advocated mandatory vaccination for anyone. Dr. Jon Abramson, chairman of the CDC's advisory committee on immunization practices said in February 2007 he opposed mandatory vaccination because sexually transmitted HPV is not a contagious disease like measles. Abramson also cited the cost of Gardasil as another reason for his opposition.
Immigrant advocates are also concerned that Gardasil's high cost would be a burden to immigrants who do not have health insurance. At $162 per shot, the 3-dose Gardasil vaccine is the most expensive vaccine on the market.
And finally, there are serious concerns about the safety of Gardasil. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
Despite growing safety concerns about Gardasil, the Food & Drug Administration (FDA) approved it to prevent two more cancers. Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.
Gardasil was approved by the FDA in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Since the CDC recommendation, Merck has been aggressively marketing Gardasil. In at least 24 states, the company is trying to convince state legislatures to make Gardasil mandatory for young girls.
Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
Gardasil may also cause more allergic reactions than other vaccines. Earlier this month, Australian researchers at the Children’s Hospital at Westmead are reported that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.
It is also not known how long the immunity from Gardasil lasts, and whether eliminating some strains of HPV will decrease the body’s own immunity to other strains. Finally, others have questioned the cost effectiveness of the expensive injections.
Still, the FDA has approved new language for the Gardasil label that states the vaccine also protects against cancers of the vagina and vulva, which affect more than 5,000 women in the U.S. each year. It was not immediately clear what the additional indication would mean for sales of the vaccine, which have fallen short of the company expectations, partly because of safety worries.
According to Forbes.com, Merck has already scaled back full-year sales estimates for Gardasil from between $1.9 billion and $2.1 billion to between $1.4 billion and $1.6 billion.
Gardasil, the Merck and Co. vaccine approved to target the human papillomavirus (HPV), is again at the epicenter of controversy. Australian researchers are reporting that young women in Australia who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs. The researchers reported that the Gardasil reactions were unusual and manageable.
The researchers were led by Dr. Julia Brotherton of The Children's Hospital at Westmead and studied 114,000 young women vaccinated with Gardasil as part of a 2007 vaccination program in New South Wales. Of the girls vaccinated, 12 experienced suspected cases of anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, nausea, and rashes. Eight of the 12 experienced “an estimated rate of reaction of 2.6 per 100,000 doses administered” as compared with “a rate of 0.1 per 100,000 doses in a 2003 school-based meningitis vaccination program.” In a commentary on the study, Dr. Neal Halsey of Johns Hopkins University in Baltimore wrote, "It's just a reminder that there are rare adverse effects. It doesn't change the strong recommendations for all adolescent girls to get this vaccine but we just have to watch them to make sure they don't have this allergic reaction," he added.
Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck & Company—Gardasil’s maker—said 16 million doses have been administered since its approval. Last May, the U.S. Centers for Disease Control and Prevention (CDC) said Gardasil is linked with a higher risk of fainting that, in some cases, resulted in injury. In July, Gardasil was criticized for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection. In June, Merck added more possible adverse reactions to Gardasil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough.
Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Recently, 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.
U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
Since the CDC recommendation, Merck has been aggressively marketing Gardasil. In at least 24 states, the company is trying to convince state legislatures to make Gardasil mandatory for young girls. One of those states was Texas, where mandatory Gardasil vaccination became the subject of a contentious debate in 2007. That year, Gov. Rick Perry issued an executive order that would have required schoolgirls to be inoculated with it. Eventually, however, Perry's order was overturned by the state legislature.
As the debate over Gardasil has grown louder, opponents of vaccination are often portrayed as social conservatives whose biggest concern is that girls will become sexually active once they receive it. But this new study indicates that such worries may have little to do with mothers' attitudes towards Gardasil.
The study, published in the September Journal of Adolescent Health, surveyed about 150 mothers at a UTMB pediatric clinic in 2007. The women were of mixed background, both socioeconomically and ethnically. The study found that mothers who wanted their daughters to remain virgins until marriage were just as likely to have them get Gardasil as those who didn't expect their daughters to wait until marriage to have sex.
Susan Rosenthal, a UTMB pediatric psychologist and the study's lead author, said that , "Mothers who haven't had their daughter vaccinated yet most often said they want more time to learn about the vaccine."
The moms in the survey do have a point - there are many answered Gardasil questions. For one thing, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
It is also not known how long the immunity from Gardasil lasts, and whether eliminating some strains of HPV will decrease the body’s own immunity to other strains. Finally, others have questioned the cost effectiveness of the expensive injections.
Gardasil, Merck & Co.'s vaccine, was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
Cevarix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.
In the NEJM editorial, Dr. Charlotte J. Haug writes, "Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer." Dr. Haug contends that the uncertainty surrounding the vaccines provides reason to be cautious.
According to the editorial, Gardasil and Cevarix were studied in clinical trails for at most six and a half years. It is still not known how long the immunity will last, or whether eliminating some strains of HPV will decrease the body’s own immunity to other strains.
The other NEJM article details a Harvard analysis that explored the cost effectiveness of the vaccines. Both Gardasil and Cevarix are given as a series of three injections, and can cost as much as $1,000 to complete. In Western countries, like the U.S. and Great Britain, regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don't protect against all HPV strains known to cause the cancer.
To measure the health benefit of vaccination, the researchers looked at the cost savings from preventing cervical cancer with the vaccine and Pap tests compared with prevention via the tests alone. A treatment is typically considered cost effective if it is less than $50,000 or $100,000 for one additional year of life
The Harvard analysis predicted that it would $43,600 to extend life expectancy by one year when girls are vaccinated at 12. When girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26, the study found. That's because vaccination is less effective after a woman is sexually active, and may have already been exposed to HPV.
However, the analysis assumed that Gardasil and Cevarix will be effective for life - something that is as of now unknown - and that women get regular screenings to detect the first signs of cervical cancer. If the vaccine's protection against HPV stops after 10 years, the cost of vaccinating preteen girls would more than triple to $144,100 per year of life gained, the study said. In those case, the researchers said that cervical cancer prevention through Pap testing alone would make more sense from a cost standpoint.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
That's when Merck's Gardasil marketing campaign really took off. And according to a recent article in The New York Times, those efforts haven't just include catchy commercials. Hundreds of doctors across the country have been recruited and trained by Merck to give talks about Gardasil. The Times reports that those doctors can be paid as much as $4,500 for a lecture, with some making hundreds of thousands of dollars as a result of their Gardasil work. Merck has also held receptions for politicians and other officials where they are urged them to pass legislation that, among other things, would make Gardasil mandatory in many states.
Merck has seen a big payoff from these efforts. According to The New York Times, Gardasil has now been made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion. Proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.
But critics of Merck say the company has overstated Gardasil's proven potential. Gardasil was only studied in clinical trials for five years. Some data from those trials indicated immunity may wane after three to five years. That means young girls immunized at 11 could have no protection by the time they enter college.
Others say Merck is exploiting fears of a type of cancer that can be easily prevented through regular Pap tests. In fact, cervical cancer has not been a major killer in western countries like the U.S. for decades. And Gardasil vaccination doesn't even eliminate the need for regular Pap tests because it doesn't protect against all forms of HPV.
Then there are the reported Gardasil side effects. According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis. Earlier this week, Australian regulators said they were investigating three cases of pancreatitis that followed Gardasil administration.
No one can say for sure if any of these side effects are the result of Gardasil. But many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the FDA expedited Gardasil's approval application, and gave it the ok in just six months. It was recommended by the CDC just weeks later.
A researcher who worked on Gardasil clinical trials told The New York Times that both the CDC and FDA acted too quickly. Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, said that most vaccines take three years to get such a CDC recommendation, and then 5 to 10 more for universal acceptance.
Despite her work on the vaccine's development, Dr. Harper has been quoted in many media outlets criticizing the speed of Gardasil's approval, as well as Merck's marketing push. "In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”
In Australia, three women developed pancreatitis shortly after the administration of Gardasil. Acute pancreatitis is a sudden, debilitating attack of severe upper abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. Complications include respiratory, kidney or heart failure, all of which can be fatal.
One of the Australian women is still under the care of a doctor, while a second recovered after a few days. An account of a third patient's experience recently appeared in the Medical Journal Of Australia.
According to that article, the 26-year-old woman was admitted to the hospital four days after receiving her first dose of Gardasil. She presented with a fever, rash, severe pain and vomiting and was diagnosed with pancreatitis. After 10 days the symptoms settled and she was discharged from the hospital.
An extensive investigation could find no other cause for the pancreatitis and while a coincidental illness could not be ruled out, the authors of the article said that the Gardasil vaccine could not "be excluded as a potential cause". They wrote that pancreatitis should "be considered in cases of abdominal pain following HPV vaccination."
The concerns raised by the article have prompted Australia's Therapeutic Goods Administration (TGA) to investigate the potential Gardasil - pancreatitis link. The TGA will try to establish if the vaccine does pose a threat or whether the cases were mere coincidence.
According to the TGA, 3.7 million doses of Gardasil, have already been distributed in Australia and to date there have been about 1,013 reported adverse reactions. These have included soreness, swelling, redness or other reaction at the injection site, headaches, dizziness, nausea and vomiting.
In the U.S., there have been thousands of reports of side effects following Gardasil vaccination. According to an analysis released June 30 by the Washington, D.C.-based public interest group Judicial Watch, there have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to Vaccine Adverse Event Reporting System (VAERS), included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
VAERS is a voluntary system used by doctors, patients and drug companies to report side effects with vaccines to the FDA. However, a 2004 study published in the New England Journal of Medicine found that only around 10 percent of all side effects are ever reported to VAERS. So the true number of Gardasil side effects could be significantly higher.
According to the Judicial Watch report, Gardasil side effects reported since its approval to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barr © syndrome, an autoimmune disorder that can result in paralysis.
VAERS is a voluntary system used by doctors, patients and drug companies to report side effects with vaccines to the Food & Drug Administration (FDA). However, a 2004 study published in the New England Journal of Medicine found that only around 10 percent of all side effects are ever reported to VAERS. So the true number of Gardasil side effects could be significantly higher.
Right now, it has not been proven which side effects were caused by Gardasil. But the shear number indicates that the issue needs more study - something that neither Merck nor the FDA seem willing to do.
What also needs more study is Merck's claim that Gardasil prevents 70 percent of all cervical cancer. Gardasil protects against the two strains of Human Papillomavirus (HPV) most likely to cause cervical cancer, but experts say that is not enough to back Merck's assertions. In an article in the Sun-Sentinal, Dr. Karen Smith-McCune, an obstetrician and gynecologist at the UC San Francisco School of Medicine, said that tests of Gardasil before the FDA approved it didn't run long enough to prove that conclusively - especially since it can take a decade for someone exposed to HPV to develop the cancer.
"Even though it guards against two HPV strains, the other HPV types need to be taken into account," Smith-McCune says. "It will take a long time before we know the true efficacy of the vaccine."
Another researcher who actually worked on Gardasil clinical trials also disputed Merck's 70 percent claim in the same article. "If we vaccinate every single 12-year-old, it should reduce by half the number of cervical cancers in the next 35 years," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School. "With Pap screening, we've reduced it by nearly 75%."
In May during an interview with a Florida TV station, Dr. Harper criticized Merck’s efforts to make Gardasil mandatory. In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.
“On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process,” Merck CEO Dick Clark said. “Concerning supplements, we have at least two supplements with the FDA concerning Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] and they will move through the [review] process,” he said. Merck states the supplements are for expanded labeling for Gardasil and that it will respond to an FDA complete response letter for the use of the vaccine in women 27–45 years of age.
Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck said 16 million doses have been administered since its approval. Last month, Merck added more possible adverse reactions to Gardasiil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough. Merck doesn't list blood clots as a Gardasil risk, and doesn't warn of adverse reactions with other drugs.
Katherine Davison, 20, suffered a stroke after receiving a second Gardasil injection. Davison began feeling dizzy and developed flu-like symptoms; she lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. "Before the shot I was fine, and there is no reason I should have had a stroke," said Katherine who says she still can't sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily.
Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released last month by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. Fourteen-year-old Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s symptoms began soon after she received her second Gardasil shot and seemed to match many of the 5,000 reports filed through a national database. Recently, 13-year-old Jenny, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; Jenny is now almost completely paralyzed.
Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Just weeks after its approval, the CDC recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls.
As of June 30, 2008, there have been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 6 percent were deemed serious. The adverse event reports included 20 deaths, as well as reports of a rare neurological condition called Guillain-Barr © Syndrome.
Despite these disturbing reports, the FDA and CDC are standing by Gardasil. "There was not a common pattern to the deaths that would suggest they were caused by the vaccine," the FDA and CDC said in a statement.
Regarding other serious problems reported in relation to Gardasil, the CDC and FDA claimed the data "do not currently suggest an association" between Gardasil and the conditions.
Earlier this month, the FDA and Merck announced that the prescribing information for Gardasil was being updated to include warnings about some of the more minor reactions seen after the vaccine, including joint and muscle pain, fatigue, physical weakness and general malaise. At the time, FDA spokeswoman Karen Riley told The Washington Times that the label updates have “nothing to do with” the serious cases that have been reported. She said the updates were made at Merck’s request and touch on possible “mild” symptoms.
Meanwhile, efforts are still underway in some states to place Gardasil on the roster of vaccines that are mandatory for girls. Even one researcher who worked on Gardasil is against such a move. Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil. In May during with a Florida TV station, Dr. Harper criticized Merck’s efforts to make Gardasil mandatory. In the interview, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.
Merck is also moving ahead with plans to obtain approval to have Gardasil administered to boys.
Mary Davison daughter Katherine, 20, and her two younger sisters received their first Gardasil shots in November 2007—three shots are given over six-months—their second this January. Katherine began feeling dizzy and developed flu-like symptoms on February 1; on February 2, her family doctor gave her a phenergan shot for vomiting believed caused by the flu. On February 3, Katherine lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. Physicians determined she suffered a stroke, but her doctors and doctors at Johns Hopkins were unable to determine the cause. Merck doesn't list blood clots as a Gardasil risk, and doesn't warn of adverse reactions with other drugs. "Before the shot I was fine, and there is no reason I should have had a stroke," said Katherine who says she still can't sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily. Mary Davison said her family doctor told her not to bring her younger two daughters in for their third shot.
Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released last month by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. Fourteen-year-old Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s symptoms began soon after she received her second Gardasil shot and seemed to match many of the 5,000 reports filed through a national database. Recently, 13-year-old Jenny, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle diseasel; Jenny is now almost completely paralyze
d.
U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.
Now, one Northern California family is wondering if Gardisal injections have nearly paralyzed a healthy 13-year-old girl. Jenny’s story was recently highlighted on CBS News and focused on how Jenny was seemingly healthy 15 months prior to receiving her third shot of Gardasil. Following the third Gardasil injection, Jenny began showing signs of having been stricken with a degenerative muscle disease. The family says Jenny is now almost completely paralyzed and believes "there may be a link” between the paralysis and the Gardasil injection and has opened a blog in the hopes of determining if Jenny’s paralysis and Gardasil are, indeed, linked and is urging other girls with similar “post-vaccination” responses to speak out at: http://www.jenjensfamily.blogspot.com/
Merck’s response? "Based on the facts that we've received, the information does not suggest that this event was causally associated with vaccination." Also, the U.S. Centers for Disease Control and Prevention (CDC) recommends 11- and 12-year-old girls receive Gardasil as part of school vaccination efforts.
But there have been problems. Serious problems. U.S. News & World Report says there have been other possible adverse side effects linked to Gardasil and the New York Post reports that Gardasil has been associated to medical problems. We also recently reported on a 14-year-old girl named Katherine Kimzey who experienced debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said. CBS News stated that other reports of possible problems stemming from Gardisil have been received on the CDC and FDA's VAERS (Vaccine Adverse Event Re
porting System), on which anyone can report side affects they feel they are having to a drug or shot.
Despite the adverse reactions emerging in girls following Gardasil injections, researchers are now looking at whether Gardasil should be given to boys to prevent HPV transmission in the rarer and deadly cancers that can occur in men and Merck is collecting data to “consider whether boys should receive the inoculation as well.”
According to the Centers for Disease Control (CDC), there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. About 7 percent of the reported side effects were serious, including 15 deaths and 31 instances of Guillain-Barr © Syndrome (GBS), a neurological condition that causes temporary paralysis.
According to The Washington Times, in June, the FDA decided to expand the possible adverse reactions to the drug to include joint and muscle pain, fatigue, physical weakness and general malaise. The new warning will be added to the package insert and to an information sheet given to patients.
But FDA spokeswoman Karen Riley told The Washington Times that the label updates have "nothing to do with" the serious cases that have been reported. She said the updates were made at Merck's request and touch on possible "mild" symptoms.
"The bottom line is that we have not seen any safety signals in the adverse events other than [fainting]," she said. "We continue to look at these reports."
However, many are not convinced and are calling on the FDA to take another look at Gardasil. Tom Fitton, president of Judicial Watch, a conservative organization that has monitored Gardasil adverse event reports, says he does not believe Merck or federal regulators are taking the side effect reports seriously. "I think we've uncovered a lot of disturbing things about Gardasil," Fitton told the Times. "All we're asking for is further investigation of its safety."
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. Merck also claimed that Gardasil was practically side effect free.
But over the past year, concerns over the safety of the vaccine have mounted. Yesterday, the Centers for Disease Control (CDC) announced that there were 7,802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). About 7 percent of those reports were for serious problems. The CDC said 31 people developed Guillain-Barr © Syndrome (GBS) - a neurological condition that leads to temporary paralysis - after receiving the vaccine. Another 15 patients died after receiving Gardasil.
The VAERS report was preceded by several high-profile news stories about young women who experienced paralysis after receiving Gardasil. Lawsuits against Merck are pending in two of those cases. In a third, the father of a California girl is waging a very public campaign to try to determine if Gardasil is responsible for his daughter's near-total paralysis.
So far, the CDC has not been able to determine if any of these reactions were caused by Gardasil, but the concerns are expected to take a toll on sales of the vaccine. Already, several drug industry analysts have downgraded Gardasil sales forecasts, a development that was followed by drop in the price of Merck stock.
In an attempt to stem the bleeding, Merck issued a statement saying it had analyzed relevant data relating to the side effects, and concluded the reported events could be seen in the general population, even in the absence of vaccination. So basically, the company is considering these incidents to be coincidences. The statement said Merck is still "confident in the safety profile of Gardasil".
Both the CDC and Merck said they will continue to study the Gardasil side effect reports. Still Merck is standing by Gardasil, and the CDC has not changed its recommendation that young girls be given this questionable drug.
Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Just weeks after its approval, the CDC recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls.
According to the CDC, there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. VAERS receives reports of adverse events that occur after people receive vaccines.
According to the CDC, VAERS received 15 reports of death following Gardasil vaccination in the US. The CDC says it has not been able to establish a link between Gardasil and 10 of the deaths. The agency did not have enough information about the remaining five to make any determination.
According to the CDC, while Gardasil was being tested in the US before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.
VAERS also received 31 reports of Guillain-Barr © Syndrome (GBS), an illness that leads to temporary, but often total body paralysis, after Gardasil vaccination in the US. Ten of those cases have been confirmed, five of which occurred when Gardasil was administered with another vaccine.
In a statement, Merck insisted that an adverse event report "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination." Merck said it would continue to evaluate reports of adverse reactions. It said it "updates product labels with new safety information as appropriate."
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Recently, the FDA refused to approve the use of Gardasil in women ages 27-45, but Merck is working to convince the agency to approve it for boys.
Merck claims Gardasil is practically side-effect free. But reports in the last year have contradicted those claims. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine. Since the Judicial Watch report, more Gardasil adverse events have been reported to the FDA. Those reports now total 8,000 and include nausea, vomiting, seizures, paralysis, autoimmune disorders and 18 deaths which are under investigation due to the timing between the receipt of the vaccine and the young women's deaths.
According to a recent article in US News and World Report, 13-year-old Jenny Tetlock began experiencing muscle weakness about a month after receiving Gardasil. Within 15 months, the California native was almost completely paralyzed. Both Merck and the FDA have dismissed suggestions that Jenny's condition is related to Gardasil.
But the girl's father, a psychology professor at UC-Berkley, is not convinced that Gardasil did not play some role in his daughter's illness. According to US News, Philip Tetlock believes Jenny may carry genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that's thought to be triggered by an overactive immune system, and her grandmother died of a nervous system disease.
At least two other girls have experienced paralysis after being administered Gardasil, and both have filed suit against Merck. According to her lawsuit, Jessica Parsons, 15, has been ill and in and out of the hospital since she received Gardasil. Her lower arms and legs were paralyzed as a result, but she is now learning to walk again.
Brittany LeClaire, 13, alleges that she suffered paralysis as well within days of receiving her last dose of Gardasil. She began having severe headaches and lethargy immediately after the injections, and then developed paralysis in her left leg. Following weeks of having to use a walker, Brittany still walks with a limp.
Unfortunately, Gardasil has not been subjected to enough testing to insure its safety. Even one of the researchers who worked on this vaccine has made this argument. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory.
In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Merck has been working on expanding the approved uses of Gardasil in an effort to spur sales growth. But in a letter to the company, the FDA said there were questions that Merck will need to answer before the agency can complete its review. Merck would not specify what those questions were, but said it would reply to the FDA's letter next month.
Some experts have questioned the wisdom of approving Gardasil for the older group, because most women in that age group who are sexually active have already been exposed to the strains of HPV Gardasil is supposed to prevent.
Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of HPV, and is dropping those efforts. However, the company still plans to work to gain approval for Gardasil to be administered to boys.
Gardasil has been the subject of controversy ever since Merck introduced it. Just weeks after its approval, the Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck has made similar efforts in Europe. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.
But many have questioned Merck's heavy-handed attempts to make Gardasil mandatory, as well as the company's claims that it is virtually side effect free. Earlier this month, the European Medicines Agency reported that two young women died shortly after being administered Gardasil, and three such deaths have been reported in the US.
A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency.
As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch is not along in voicing concerns about the safety of Gardasil. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.
The American Social Health Association reports that over half of all people will suffer from a sexually transmitted disease or infection at some point in their lives. The human papillomavirus, or HPV, is one of the least noticeable, but potentially most life-threatening of such infections. Worse, most HPV carriers are never diagnosed and never realize they carry the virus. HPV is the leading cause of cervical cancer and has become the second-leading cause of cancer death for women worldwide.
"It's never detected, they are never aware of it, and their immune system suppresses it before they ever know about it in the vast majority of cases," said Fred Wyand, spokesman for the American Social Health Association.
Researchers are now looking at whether Gardasil should be given to boys to prevent HPV transmission in the rarer and deadly cancers that can occur in men. "There is probably no reason to think it would not be effective in boys and because HPV is passed back and forth, immunizing a large part of the population would limit transmission," said Dr. Jonathan L. Temte, associate professor in the Department of Family Medicine at the University of Wisconsin School of Medicine and Public Health. Although men don't risk cervical cancer, they are half of the equation when it comes to sexually transmitted diseases and are at increased risks for throat, genital, and anal cancers from HPV infection. The maker of Gardasil, Merck & Co., is collecting data to “consider whether boys should receive the inoculation as well.”
Gardasil was approved by the FDA two years ago for girls aged 9-26 and protects against sexually transmitted diseases caused by four particularly dangerous strains of HPV in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Three shots are given over six-months. Merck said 16 million doses have been administered since its approval.
The U.S. Centers for Disease Control and Prevention recommends 11- and 12-year-old girls receive Gardasil as part of school vaccination efforts. But there have been serious problems. A 14-year-old girl named Katherine Kimzey experienced debilitating headaches, fainting spells, and arthritis-like stiffness. She became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Because Katherine’s symptoms began soon after she received her second shot and symptoms seemed to match many of the 5,000 reports filed through a national database that monitors vaccine safety, Katherine’s mother, Michelle, believes the problems stem from Gardasil. "When you read everybody's stories, they're too similar not to be related," Kimzey said.
In January, we reported on the deaths of two young women oversees that were apparently linked to Gardasil. Those deaths followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions. Last week, European regulators reported two more Gardasil linked deaths.