HPV Vaccine Victims Pile Up: $1.5B for Merck

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HPV Vaccine Victims Pile Up: $1.5B for Merck
by Barbara Loe Fisher

While Merck has pulled in $1.5B from sales of GARDASIL vaccine worldwide, there are continuing reports that girls are being crippled and dying after getting the HPV vaccine fast tracked and licensed by the FDA in 2006. Although the roll-out of GARDASIL with an unparalleled multi-million dollar mass media advertising blitz has created a profitable market for the drug company that took huge losses from Vioxx injury/death lawsuits, the persistent reports of Guillain Barre Syndrome (GBS) paralysis, arthritis, seizures and sudden loss of consciousness within 24 hours of vaccination continue to haunt the marketing campaign.

Last week Judicial Watch issued a report on more than 8,000 GARDASIL reaction reports to the federal Vaccine Adverse Event Reporting System (VAERS) obtained under the Freedom of Information Act (FOIA). A search of the VAERS database , which includes reaction reports through April 30, 2008 released to the public by the FDA, reveals nearly 6,700 reports of injury and death after GARDASIL. Two GARDASIL vaccine injury claims recently were filed in the federal Vaccine Injury Compensation Program under the National Childhood Vaccine Injury Act of 1986.

Exactly two years ago, NVIC sounded the first public warning about GARDASIL risks pointing out that Merck had not adequately proven the vaccine was safe and effective to give to girls under age 16. NVIC pointed out that pre- licensure trials were flawed because they used an aluminum containing placebo that may have masked the true reactivity of GARDASIL, which also contains 225 mcg of aluminum. Like mercury, aluminum can cause inflammation in the body and kill brain cells.

The fact that Merck had only studied the vaccine in fewer than 1200 girls under age 16 and followed them up for less than two years before licensure did not seem to bother doctors working for the CDC's Advisory Committee on Immunization Practices (ACIP), who saluted Merck smartly and promptly recommended that all 11 year old girls entering sixth grade get three doses.

By the end of 2006, Merck had marshaled its well- paid lobbying forces bolstered by a flashy television advertising campaign in an unprecedented effort to persuade legislators in every state to turn CDC recommendations into law and pass HPV vaccine mandates. Texas Governor Rick Perry went so far as to issue an Executive Order mandating the vaccine for all sixth grade girls.

GARDASIL had only been on the market for a few months and nobody, including Merck, knew the full range of side effects when GARDASIL was given to millions of girls entering puberty. Nevertheless, the pressure was on young girls, their parents and state legislators to trust blindly that the vaccine had no real risks.

In early 2007, NVIC again warned the public that there were significant risks associated with GARDASIL , especially when it was combined with other vaccines. NVIC warned that there was evidence that giving GARDASIL during active HPV infection may increase the risk for cervical cancer while girls were not being tested for active HPV infection before getting vaccinated. NVIC also advised that girls should not drive home after getting the shot because of the risk for sudden loss of consciousness after leaving the doctor's office.

In March 2007, the CDC admitted that there was no scientific evidence that GARDASIL can be safely co- administered with other vaccines (like TDaP, meningococcal, varicella, MMR, influenza). Even so, without a second thought, the CDC urged doctors to assume safety and go ahead and give GARDASIL simultaneously with other vaccines.

By end of May 2007 almost every state had rejected proposed mandates for GARDASIL vaccine and there were more than 2,000 GARDASIL adverse events reported to VAERS. In August 2007, NVIC released a comprehensive analysis of GARDASIL reaction reports to VAERS and a critique of the CDC's universal use recommendation. In a letter, NVIC asked the CDC to warn doctors that the simultaneous administration of Menactra with GARDASIL increases the risk for GBS and other serious adverse event reports.

The CDC chose to blow off NVIC's report and do nothing.

Two years after licensure, it is clear that GARDASIL has plenty of risks for young girls. Among the more than 130 GARDASIL reaction reports that have been filed with NVIC's 26-year old Vaccine Reaction Registry is one that was posted by a mother, who witnessed what happened to her daughter on the International Memorial for Vaccine Victims.

Amanda's mother describes her daughter as "a beautiful, active girl that was brought down." Only 14 when she was vaccinated, Amanda "became weak, tired and sick to her stomach" but the symptoms subsided. One week after the second HPV vaccination, her legs "became very weak and she started losing feeling in her feet." She was hospitalized in the Intensive Care Unit for four days with a diagnosis of Guillain-Barre Syndrome.

Amanda's mother said "The doctors thought we were CRAZY when we mentioned that the HPV vaccine could cause this."

"Amanda is constantly sick," says her Mom. "Something has suppressed her immune system so badly she can barely function. The depression got really bad because she is experiencing a lot of pain in her knees now and can't do any sports. She was once very active and right now can barely go to school We were told me her doctors that there is nothing more that they can do and that she could use a good psychiatrist."

How many more girls like Amanda and her mother have had their futures stolen by a vaccine that is supposed to prevent a viral infection that is cleared without any residual effects by more than 90 percent of all who get it to prevent a cancer that causes less than 1 percent of all new cancer cases and cancer deaths in the U.S. every year? Did Amanda and her mother know that cervical cancer can be prevented nearly 100 percent of the time with annual pap smears and early intervention when pre-cancerous cervical lesions are diagnosed?

Or did Amanda's Mom believe Amanda would be "one less" because a pediatrician told her so?

NVIC continues to receive reports from grieving mothers and fathers who can't find doctors to treat their once-healthy daughters who are now chronically ill and disabled after being injected with GARDASIL. In almost every case, the doctors are denying the vaccine had anything to do with what happened.

The tragic denial by the medical profession of the harm vaccines can do continues decade after decade after decade. When will doctors stop being marketers of pharmaceutical products and implementers of government policy and embrace the moral imperative to "first, do no harm?"

The "its all a coincidence" defense mounted by doctors when something bad happens after vaccination is illogical, unscientific and dangerous. When will Americans get up off their knees and stop worshipping men and women in white coats who do not know what they are doing?

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在临床试验中，Gardasil®的均未出现严重安全性问题。接种部位的副反应率为83%，对照组为73.4%。最主要的局部不良反应为接种部位红、肿、疼痛，在试验组程度更重一些。最常见的系统不良反应为发热、头疼和恶心，在试验组和对照组中发生率均为69%。在研究中未出现接种相关的死亡。在试验组和对照组分别出现5例和2例接种相关严重不良事件。试验组5例严重不良事件分别为1例支气管痉挛、1例肠胃炎、1例头疼伴血压升高、1例接种部位疼痛伴移动受阻和1例阴道出血。对照组2例严重不良事件，1例为过敏，另1例为发热、头疼伴寒战。在观察过程中，试验组10.7%对象以及对照组12.6%对象出现怀孕。62％的试验组孕妇和60％的对照组孕妇顺产。两组自发流产率均为26.1%。在接种试验苗后30天内怀孕的对象中，5例婴儿具有先天异常，而对照组无一发生，差别不具统计学意义。在美国新生儿先天异常率约为2%~4%。试验组出现的这些先天异常种类均不同，经专家审查认为与疫苗无关。在接种疫苗30天后怀孕的对象中，试验组出现10例先天异常婴儿，而对照组出现16例。在在对Gardasil®的2006年上市后监控中，美国疫苗不良反应报告系统VAERS截至2008年6月份共收到了9,749 份接种后的不良反应的报告。在这其中有94%的报告属于轻微不良反应，有6%属于严重不良反应。轻微不良反应主要集中于注射部位疼痛，肿胀，昏厥，哮喘等等。而在严重不良反应中，目前共有20例死亡的病例报告，但是经过分析，上述死亡病例均与接种Gardasil®无关。此外，还有多例关于格林巴利综合征的报告，但是FDA在研究了相关资料后认为，目前尚无证据表明格林巴利综合征的发生与Gardasil®的接种有直接关系。因此，FDA认为，就目前的数据来看，Gardasil®是一种安全有效的疫苗，但是，仍然需要继续进行上市后监控，以便及时发现少见的严重不良反应。

摘自dudupan博士论文的。

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Gardasil vaccine 是由Merck生产的四價人類乳突病毒類病毒顆粒疫苗 (Human Papillomavirus Virus-Like Particle vaccine; HPV VLP vaccine) 是一種無菌的液態懸液劑，是將第 6 、 11 、 16 及第 18 型人類乳突病毒之主要外鞘蛋白 (L1) 所形成的類病毒微粒 (Virus-Like Particles; VLPs) 予以高度純化後製備而得。 四价人类乳突病毒类病毒颗粒疫苗 (Human Papillomavirus Virus-Like Particle vaccine; HPV VLP vaccine) 是一种无菌的液态悬液剂，是将第 6 、 11 、 16 及第 18 型人类乳突病毒之主要外鞘蛋白 (L1) 所形成的类病毒微粒 (Virus-Like Particles; VLPs) 予以高度纯化后制备而得。 L1 蛋白是分別以基因重組酵母菌 Saccharomyces cerevisiae CANADE 3C-5 （菌株 1895 ）發酵產生，並且自行組裝成 VLPs 。 L1 蛋白是分别以基因重组酵母菌 Saccharomyces cerevisiae CANADE 3C-5 （菌株 1895 ）发酵产生，并且自行组装成 VLPs 。 再將純化後的 VLPs 吸附於含鋁佐劑 ( 非晶形羥基磷酸鋁硫酸鹽 ) 上。 再将纯化后的 VLPs 吸附于含铝佐剂 ( 非晶形羟基磷酸铝硫酸盐 ) 上。 此四價 HPV VLP 疫苗乃是一種由已吸附佐劑的各型 HPV VLPs 、含鋁佐劑配方及緩衝溶液製備而成。 此四价 HPV VLP 疫苗乃是一种由已吸附佐剂的各型 HPV VLPs 、含铝佐剂配方及缓冲溶液制备而成。

据统计 Gardasil 2007 上半年的销售额为 7.23 亿美元，销售单价(美元 US$): 193 美元 ，(人民币 RMB): 1,370 元。
然而在美国8000多人使用后却发现其包括休克，口疱，昏迷等严重的副作用。