中国でのサーバリックス接種開始が、２０１７年に予定されていることを懸念する中国人のブログから
Question: Were the Chinese women enrolled for the clinical trial informed that HPV vaccination might be associated with a higher rate of deaths in Asian women than in other races as reported by a U.S. FDA review [2]?
FDAのレビューで他の民族よりもアジアの女性で死亡率が高いことを治験にエンロールした中国女性に伝えたかどうか？
以下は、このレビューの該当箇所です。リンク
治験中の死亡例は８件、そのうち７件がガーダシル、１件がプラセボ
８件中アジアの女性が７人、ラテン系が１人
A total of 8 deaths occurred during the study - 7 in the Gardasil group and 1 in the placebo group. What follows is a narrative summary of each case:
Gardasil （ガーダシル）
AN 81322: 34yo Asian female diagnosed with pulmonary tuberculosis on Day 139 postdose 2. The subject was noncompliant with medical therapy, including being discharged from the hospital against medical advice during an episode of respiratory distress. She died 4 months later of acute respiratory failure due to pulmonary tuberculosis.
AN 81654: 32yo Asian female with history of hepatitis B (diagnosed Feb 2006) and hyperthyroidism (diagnosed in May 2005 – approximately one month postdose 2), was vaccinated with her first, second, and third doses of qHPV vaccine on 18-Feb-2005, 26-Apr-2005, and 13-Aug-2005, respectively. On approximately Day 203 postdose 3, the subject hospitalized for treatment of thyrotoxicosis. The subject was discharged against medical advice, and died on 05-Mar-2005, one hour after discharge, with cardiorespiratory arrest due to cardiac failure secondary to thyrotoxicosis.
AN 84097: 39yo Hispanic female was diagnosed with systemic lupus erythematosus on Day 671 postdose 3. Approximately 3 months later, the subject was hospitalized to rule out a coronary event and a possible pulmonary thromboembolism. After 4 days of treatment, the subject died of cardiac arrest.
AN 84366: 43yo Asian female was hospitalized on Day 571 postdose 3 for abdominal hysterectomy for uterine fibroids. The subject died of a massive pulmonary embolus 12 days post-operatively.
AN 81011: 26yo Asian female was diagnosed on Day 250 postdose 3 with breast cancer. Two years later, the subject died; immediate cause of death was cardiomyopathy and lung and liver metastases secondary to breast cancer.
AN 83962: 36yo Asian female was admitted to the hospital on Day 859 postdose 3 with a hemorrhagic stroke. She died the following day after uncal herniation.
AN 84150: 40yo Asian female diagnosed on Day 1059 postdose 3 with nasopharyngeal carcinoma. The subject died ~3 months later of cardiorespiratory arrest secondary to brain metastases.
Placebo
AN 81009: 34yo Asian female was diagnosed on Day 595 postdose 3 with acute lymphoblastic leukemia. The subject died one month later of a pulmonary thromboembolis.
治験総数 ３８１９人 （比率）
Race/Ethnicity: Asian 1192 (31.2) 参加総数のうちのアジア人は３１．２％
Race/Ethnicity: Black 182 (4.8) 黒人
Race/Ethnicity: Hispanic American 1649 (43.2) ラテン系アメリカ人
Race/Ethnicity: White 785 (20.6) 白人
Race/Ethnicity: Other 8 (0.2) その他
陰謀論には与しませんが、先天的あるいは後天的な素因があるのかもしれません
日本人には日本人での治験が必要でした
david 