Wednesday, April 6, 2016

(日本疫苗風暴) 集體訴訟: 子宮頸癌疫苗 (Cervarix by GSK/ Gardasil by MSD)

子宮頸癌疫苗現副作用日女控告政府及藥廠 0331(on.cc東網專訊】 在日本,12名女士接種子宮頸癌疫苗後,出現全身疼痛、麻痹等副作用,她們計劃今年7月底前提出集體訴訟,向日本政府、葛蘭素史克和默克公司(MSD)兩間製藥公司索償,是日本首次有人因子宮頸癌疫苗引起副作用而提出訴訟。4名女事主昨日在東京召開記者會,指日本政府任由有問題疫苗流通,致受害範圍擴大。 來自埼玉縣的21歲女大學生酒井七海、18歲的平原沙奈、來自奈良縣的17歲高中生谷口結衣,以及來自山梨縣的17歲高中生望月琉菜,在記者會上講述她們遇到的問題。其中谷口表示,疫苗的副作用令她劇烈頭痛,有時會短暫失去視力。 涉事子宮頸癌疫苗於200912月在日本上市。日本厚生勞動省指,至201411月為止,約338初中及高中生接種這批疫苗,其中2584人出現副作用。現時,該12名女性已決定入稟法院提控。其律師團隊呼籲全國各地的受害女性加入訴訟,他們將在東京、名古屋、大阪、福岡的地方法院,提出訴訟。今次將被起訴的兩間製藥公司,分別是葛蘭素史克所製的「卉妍康」和默克公司的「加衞苗」子宮頸癌疫苗。日本政府亦被指批准問題疫苗流通,並將其列為公費補助和定期接種疫苗,沒有履行顧及安全的義務,違反了有關規定。默克公司其後發表聲明,指疫苗經過臨床試驗,有「壓倒性的科學證據」證明安全,也得到世界衞生組織(WHO)認證,無證據指病徵與疫苗有關,指原告沒有足夠的依據。葛蘭素史克及日本厚生勞動省則回應指,由於對目前的訴訟內容不太清楚,暫不發表任何評論。

Women in pain plan lawsuits over cervical cancer vaccines  THE ASAHI SHIMBUN March 31, 2016  At least 12 young women will sue the government and two drug companies over what they say are the debilitating side effects from approved--and briefly recommended--vaccines against cervical cancer, lawyers said March 30. In the damages suits that will be filed in June at the earliest, the plaintiffs will argue that the government and pharmaceutical giants GlaxoSmithKline Plc and MSD KK failed to take safety precautions although they were in a position to expect possible health problems from the vaccinations. The 12 would-be plaintiffs, including high school and college students, reside in areas ranging from Hokkaido to Fukuoka. The lawsuits will be filed with the district courts in Tokyo, Nagoya, Osaka and Fukuoka. "I have suffered for the past five years because few therapies were available to treat my side effects despite the understanding that vaccination could trigger such problems," Nanami Sakai, a 21-year-old college student who uses a wheelchair, said at a news conference in Tokyo on March 30. "I would like to know why I had to suffer and why I could not get appropriate treatment right away." Sakai, who is from Saitama Prefecture, was vaccinated twice, in February and March 2011, when she was a first-year student at high school. A day after the second shot, she lost consciousness and started having headaches and waves of dizziness. Despite being hospitalized 22 times, she said her health condition worsened. Sakai now needs a special device for her right foot to stand up and is also suffering from impaired vision. She said her health problems forced her to give up her dream of becoming a lawyer. Her lawyers said the number of plaintiffs could rise. They plan to work in tandem with the Tokyo-based Representative of Japan Cervical Cancer Vaccine Sufferers Organization. The organization, set up in March 2013, said it has been involved in about 2,800 consultations concerning cervical cancer vaccinations. It said about 500 people, many of them teenagers, were confirmed to be suffering from side effects. MSD, however, said it is prepared to "present evidence in court" showing its vaccine has not caused health problems. "There is scientific evidence (for the effectiveness and safety of the vaccine), we believe that there are no grounds for the existing claims made by the Representative of Japan Cervical Cancer Vaccine Sufferers Organization," the company said in a statement released on March 30. GlaxoSmithKline declined to comment, saying it does not know the full details of the planned lawsuits. The Ministry of Health, Labor and Welfare has been looking into the cause-and-effect relationship concerning the vaccines, but it also declined to comment. The ministry authorized sales in Japan of Cervarix, a vaccine by GlaxoSmithKline, in October 2009 and MSD's Gardasil in July 2011. Their applications were filed in 2007. After the Cabinet decided to promote vaccinations against cervical cancer as a priority program in 2010, free shots were available in almost every part of the country in November that year. The number of females who were vaccinated soared, although it was up to each individual to decide whether to receive the shots. The government in April 2013 recommended the vaccinations for sixth-graders through first-year high school students. But this recommendation was withdrawn two months later following a series of reports about serious health problems. By that time, an estimated 3.4 million women had been inoculated against cervical cancer. The ministry said it had received 2,700 reports about suspected side effects by the end of June 2015. In January 2014, a panel of experts at the ministry issued a report that said the suspected cases of side effects were the result of "physical and mental reaction" stemming from pain and fear about injections. The lawyers dispute this conclusion, arguing that studies of the suffering of the patients show there is causal relationship between the vaccines themselves and the health problems. Runa Mochizuki, a second-year high school student from Yamanashi Prefecture, was vaccinated when she was a sixth-grader. "My life was taken away by a single shot of vaccine," Mochizuki, 17, who has trouble walking because of pain all over her body, said at the news conference. "Those who recommended the vaccination should take responsibility." In the planned lawsuits, the lawyers plan to fault the government for not being fully aware of severe side effects being reported abroad when the two companies applied for sales of their vaccines in Japan. The plaintiffs will also pursue the government's responsibility for promoting the inoculations. Cervical cancer is diagnosed in about 10,000 women a year in Japan, and about 3,000 die of the disease.

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