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| Taiwan News Page 9 2010-01-22 12:00 AM |
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| By Sherlock Ho Agencies 2010-01-21 02:44 PM |
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Thursday, January 21, 2010
Taiwan News: KMT asserts ownership of Taiwan prosecutors
Tuesday, January 19, 2010
陳聰明: 沒有罪證 誓必彈劾
馬英九: 罪證如山 不聞不問
20100119 DaHwaNews 13/1
剷除陳聰明 馬英九扭轉利空局勢？
NOWnews - 34分鐘之前
檢察總長陳聰明19日被監察院彈劾，許多藍營立委叫好，不過綠營立委卻是很酸的說，「這根本就是政治打壓！」民進黨召開記者會抨擊，批「馬英九的『政治黑 手』已經明顯伸進監察院，監院甘願淪政治打手」。而國民黨在去年底縣市長選舉成績不佳、1月9日立委補選全軍覆沒，外界 ...
史上首位監院彈劾陳聰明通過 陳聰明閃電請辭傍晚出面說明 附帶條件要王清峰急速處份
台視新聞 - 40分鐘之前
中華民國史上第一次!檢察總長遭彈劾!監察院今天以8比三的票數，通過彈劾檢察總長陳聰明，彈劾文認定陳聰明在陳前總統相關案件調查中，廢弛職務、違失情節嚴重，不過傍晚5點，陳聰明卻搶先一步，向法務部提出辭呈，而晚間他也親自出面回應，表示對於這個結果感到失望。 ...
監察院彈劾 陳聰明請辭
臺灣新浪網 - 38分鐘之前
監察院通過檢察總長陳聰明的彈劾案，陳聰明第一時間已經向法務部長王清峰提出辭呈，王清峰說，會將辭呈轉交總統核准，而王清峰也對此向社會大眾道歉，她說，不管陳聰明有沒有失職，已經對總統，對社會都造成傷害。遭到監察院彈劾，檢察總長陳聰明說他無愧於心，但是決定不 ...
彈劾案 民進黨不滿陳聰明也質疑監察院立場
yam天空新聞 - 1小時之前
針對監察院通過檢察總長陳聰明彈劾案，民進黨19日不滿陳聰明在司法改革努力不夠，明顯辦綠不辦藍外，還質疑監察院彈劾陳聰明是有政治因素。 對於外界的質疑，監察委員都表明，他們無黨無派，沒有預設政治立場。 ※ 加我為撲浪好友可以看到小編推薦的新聞喔！ ...
遭監察院彈劾 陳聰明請辭
臺灣新浪網 - 1小時之前
監察院通過檢察總長陳聰明的彈劾案，法務部長王清峰第一時間出面道歉，王清峰說，不管陳聰明有沒有失職，已經對總統，對社會都造成傷害，至於監察院要求法務部急速處分，王清峰則說，等看到案文再說，而陳聰明則是對媒體表示，他無愧於心，隨後立刻請辭。 ...
中央社新聞小百科：急速救濟
臺灣新浪網 - 1小時之前
（中央社記者安芷嫻、陳亦偉台北19日電）監察院今天通過檢察總長陳聰明彈劾案，並附帶決議要法務部長做「急速救濟」；法界人士表示，急速救濟過去幾無實 例，但根據文獻，指的應是包括停職、調職等處分。 監察法第14條規定，監委提出彈劾案時，若認為被彈劾對象失職或違法 ...
陳聰明請辭 法務部得免憲政爭議
中央通訊社 - 2小時之前
（中央社記者安芷嫻台北19日電）監察院今天通過彈劾檢察總長陳聰明，並附帶要法務部對陳做類似停職的「急速救濟」。據了解，法務部原本擔心，監委作法可 能引發憲政爭議，直到陳聰明主動請辭，才化解風暴。 監委這次彈劾陳聰明，特別之處在於援引監察法第14條規定，要法務 ...
陳聰明請辭 特偵檢察官集體申請歸建
中央通訊社 - 2小時之前
(中央社記者林長順台北19日電)監察院今天通過檢察總長陳聰明彈劾案，陳聰明下午主動請辭。據了解，全數特偵組檢察官已有共識，會集體向法務部申請歸 建，讓未來新總長重新任命特偵組檢察官。 知情人士指出，陳聰明在彈劾案通過後立即找特偵組檢察官開會，陳聰明一開始就 ...
陳聰明主動遞辭呈 府：馬總統將等收到再處理
NOWnews - 3小時之前
監察院今(19)日彈劾最高法院檢察總長陳聰明，並作成急速救濟之附帶決議，移請其直屬主管長官處理，陳聰明如未調離現職，特偵組無法偵辦相關案情，法務 部若不處理則為失職。在法務部尚未有正式回應之前，陳聰明主動請辭，法務部立刻報請行政院院長鑒核，並轉馬英九總統核定 ...
彈劾陳聰明監院遭質疑配合辦案
自由時報 - 3小時之前
監察院今日通過檢察總長陳聰明彈劾案，陳聰明於傍晚面對媒體宣布請辭，並發表聲明，指遭有心人惡意攻擊，無奈的心情全寫在臉上。（記者羅沛德攝） 〔本報訊〕監察院今（19）日以8比3，通過檢察總長陳聰明彈劾案，陳聰明也立即向法務部請辭，但卻發表聲明，指出遭有心人士 ...
一度山窮水盡 監委查陳聰明案峰迴路轉
中央通訊社 - 3小時之前
(中央社記者葉素萍台北19日電)監察院通過彈劾檢察總長陳聰明，監委調查此案1年多，中間一度「山窮水盡」，辦不下去，後來是一位資深法官的關鍵證詞， 再加上當事人約詢過程漏口風，最後才彈劾成功。 監察委員李復甸指出，從2008年9月開始調查最高檢察署辦案疏失以來，陳 ...
陳聰明：被彈劾，失望、不平
中時電子報 - 3小時之前
檢察總長陳聰明遭監察院彈劾，他說他帶領特偵組努力辦案，卻仍被有心人抹煞，甚至惡意攻擊，他也為特偵組同仁感到委屈。陳聰明還說監察院竟然通過對他的彈劾案，他感到失望與不平，因而辭去檢察總長一職。 陳聰明火速辭職，隨即發表聲明，他說他帶領特偵組努力辦大案，依 ...
民意背書到監院彈劾 陳聰明毀譽參半
中央通訊社 - 4小時之前
(中央社記者林長順台北19日電)監察院今天通過檢察總長陳聰明彈劾案，陳聰明成為政府遷台後，首位遭彈劾的檢察總長。陳聰明靠苦讀從老師轉司法官，再登 檢察龍頭，如今遭彈劾請辭，仕途轉折不可謂不大。 69歲的陳聰明司法官訓練所第13期結業，歷任台北地檢署檢察長、高雄高 ...
檢察總長接任人選 外界看好黃世銘
中央通訊社 - 4小時之前
（中央社記者安芷嫻、陳亦偉台北19日電）檢察總長陳聰明今天請辭，如果辭呈獲總統批准，司法圈內多人看好獲總統馬英九、法務部長王清峰倚重的現任法務部 政務次長黃世銘，可望成為新總長候選人。 現行法院組織法規定，檢察總長由總統提名、立法院同意；總長因故出缺或無法 ...
陳聰明辭職_王清峰：由總統核定
中時電子報 - 3小時之前
檢察總長陳聰明今天遭監察院彈劾，陳聰明下午在得知遭彈劾後，火速請辭，法務部長王清峰表示，已經收到總長辭呈，並依法報請行政院鑒核，再由行政院長吳敦義轉總統府核定後處理。 監察院彈劾檢察總長陳聰明，陳聰明已提出辭呈，法務部長王清峰作了說明。 ...
陳聰明辭呈已送達總統府
自由時報 - 2小時之前
〔中央社〕監察院通過檢察總長陳聰明彈劾案，陳聰明隨即請辭。行政院發言人蘇俊賓今晚表示，行政院尊重監察院調查與陳聰明請辭決定。據了解，辭呈已送達總統府。 陳聰明得知遭監察院彈劾後立即向法務部提出辭呈，法務部將辭呈報行政院，轉總統核定。 ...
陳聰明請辭__綠委：維持風骨_藍委：開始現形
中時電子報 - 3小時之前
檢察總長陳聰明今天遭監院彈劾案後立即請辭，民進黨立委高志鵬說，陳聰明替自己維持了風骨，國民黨立委邱毅則說，陳聰明雖然請辭，但這並非是停損點，反而是陳聰明所有違法失職行為的第一張骨牌。 陳聰明遭監院彈劾後，立即遞出辭呈，民進黨立委高志鵬認為，陳聰明現在走 ...
陳聰明：有心人士惡意攻擊 深表痛心
中央通訊社 - 5小時之前
（中央社記者林長順台北19日電）監察院今天通過檢察總長陳聰明彈劾案，陳聰明下午向法務部遞交辭呈，並發表聲明。聲明中指出，部分有心人士持續不斷惡意 攻擊他及特偵組同仁，讓他深表痛心及抱屈。 陳聰明表示，他深知國人對於他個人、特偵組及全體檢察官均有高度期待，他 ...
成也扁敗也扁 陳聰明爭議多
NOWnews - 5小時之前
自從擔任檢察總長以來，陳聰明的爭議一直不曾斷過，在獲得前總統陳水扁提名檢察總長時，就曾經爆出立院關說疑雲，而在扁案審理期間，更被爆料魚翅宴花酒 宴，他和扁案關係人牽扯不清，而這些人際關係，也成了他去職的導火線。 民國98年6月10日，國民黨立委邱毅質詢，「有 ...
彈劾陳聰明 監院還決議急速救濟 將燙手山芋拋給王清峰
NOWnews - 7小時之前
在日前彈劾未成，監察院今(19)日二度開會審查後決議，以8比3彈劾最高法院檢察總長陳聰明，彈劾文認定陳聰明在陳水扁相關案件調查中，廢弛職務、違失 情節嚴重，但監委無司法權偵辦陳聰明是否涉及不法，也無作出移送法辦的決議；而依監察法第14條以7比4作成急速救濟之附帶 ...
看問題／監委李復甸否定立委李復甸？
NOWnews - 6小時之前
檢察總長陳聰明遭到彈劾，監委李復甸出面說明彈劾理由。 監察院19日通過對檢察總長陳聰明提出彈劾，並要求法務部對陳聰明進行急速處分。而提案彈劾陳聰明的監委李復甸，正是當時讓陳聰明能當上檢察總長的「推手」之一，為何監委李復甸會否定立委李復甸的決定？ ...
遭彈劾 檢察總長陳聰明提辭呈
聯合新聞網 - 6小時之前
檢察總長陳聰明中午正式提出辭呈，法務部長王清峰已轉交行政院、將由總統馬英九核定。 法務部指出，監察院中午通過對陳聰明的彈劾案，並作成急速處分的附帶決議，陳聰明即提出辭呈，法務部已報請行政院鑒核，並轉總統核定。 監察院調查檢察總長陳聰明違法失職案，上午進行 ...
陳聰明赴黃芳彥私宅 監院彈劾關鍵
中央通訊社 - 6小時之前
（中央社記者謝佳珍台北19日電）監委李復甸今天說，民國96年2月26日檢察總長陳聰明到黃芳彥私宅會面，究竟談什麼，監察院認為當中有「犯罪嫌疑」。 陳聰明缺少誠實與正直，「必須從位子上離開」。 監察院以8票成立、3票不成立，上午通過彈劾陳聰明，並通過附帶決議 ...
彈劾陳聰明民進黨:明顯政治干預
自由時報 - 6小時之前
〔中央社〕監察院今天通過對檢察總長陳聰明彈劾案。民進黨今天表示，為符合國民黨敗選報告的要求，監察院2度開會通過對陳聰明的彈劾案，顯示政治干預。 監察院今天以8票對3票，通過彈劾陳聰明，並通過附帶決議要求「急速救濟處理」。 民進黨發言人蔡其昌下午召開記者會 ...
遭監院彈劾 檢察總長陳聰明請辭
NOWnews - 7小時之前
監察院今（19）日對檢察總長陳聰明失職案召開二次審查會，通過對陳聰明的彈劾，陳聰明下午已經提出辭呈。陳聰明是第一位由總統（陳水扁）提名，經立法院同意後任命的檢察總長，也是第一位被監察院彈劾的檢察總長，同時還是第四屆監委上任以來，第一位被彈劾的現任政府 ...
請辭檢察總長 陳聰明失望不平
聯合新聞網 - 4小時之前
檢察總長陳聰明遭監院彈劾，隨後他向法務部提出辭呈，並於晚間親自出面回應表示，他個人深感失望不平，在這樣的環境下，他無法提供更好的辦案環境，故辭去檢察總長一職，希望社會能給檢察官純正的辦案空間。 檢察總長陳聰明說，對於監察院的彈劾，他個人深感失望不平，在 ...
8:3壓倒性彈劾通過 陳聰明請辭
華視新聞 - 3小時之前
身為我國司法檢察機關、最高首長的檢察總長陳聰明，今天遭到監察院、以8比3的票數，通過彈劾，創下我國監察史上的首例，監察院提出的彈劾理由認為，陳聰明參加扁家洗錢案重要關係人黃芳彥私宅聚會，毫不避嫌，嚴重影響司法威信以及政府形象，得知這個消息，陳聰明在傍晚 ...
檢察總長陳聰明閃電請辭
自由時報 - 6小時之前
檢察總長陳聰明今天下午在得知遭監察院彈劾後，立即提出辭呈。（本報資料照，記者叢昌瑾攝） 監察院今天以八比三票數，通過最高法院檢察署檢察總長陳聰明彈劾案，監委李復甸（左起）、陳永祥、錢林慧君召開記者會說明。（記者簡榮豐攝） 〔記者項程鎮、劉志原／台北報導〕 ...
綠：馬黑手進監院 彈劾案符藍敗選檢討
中時電子報 - 6小時之前
監察院今天通過彈劾陳聰明，民進黨對此也有解讀意見。民進黨發言人蔡其昌表示，檢察總長陳聰明的司法改革作為有限，確有很多改進空間，但監察院為了符合國民黨立委補選失利的檢討報告，二度開會立即通過彈劾案，顯示總統馬英九的政治黑手已伸入監察院，監察院違背獨立公正 ...
陳聰明遭彈劾請辭 馬英九：從不干預審判和檢察系統
NOWnews - 6小時之前
監察院今（19）日通過檢察總長陳聰明彈劾案，而陳聰明隨後也宣布辭職。身兼國民黨主席的馬英九總統強調，他從來不干預也不介入司法案件，不論是審判系統 或檢察系統，因此，對於彈劾案的結果，他尊重監察院職權。 由監委李復甸、錢林慧君共同調查的陳聰明案，19日二次提出 ...
Monday, January 18, 2010
A fraud the judicial system will never touch: 國光疫苗
國光疫苗 makes headline news everyday. It is suspected of killing healthy children and making people seriously ill. There is clear government cover up and collusion. The judicial system sees nothing of interest.
Just as the judicial system will not touch 貓纜和柵湖線, it will not investigate 國光疫苗. 國光疫苗's stench of fraud is just as strong, if not stronger than that of 貓纜和柵湖線:
Taipei Times
Adimmune vaccine: Saving or risking lives?
國光疫苗救命還是害命？
STAFF REPORTER
Saturday, Jan 16, 2010, Page 2 The process through which Taichung County-based biotech company Adimmune Corp came to manufacture its A(H1N1) influenza vaccine was flawed and paved the way for safety concerns that have surrounded the vaccine, a US expert on infectious diseases told the Taipei Times this week.
Ho Mei-shang (何美鄉), a research fellow at Academia Sinica’s Institute of Biomedical Sciences and former director of biotechnology research at Adimmune, disputes this view, however, saying in an interview on Tuesday that the vaccine is safe and that there was nothing wrong with the process.
The Centers for Disease Control (CDC) announced on July 13 that Adimmune, the sole bidder, had won a government contract to produce 5 million doses of the (A)H1N1 vaccine, at NT$199 per dose, for delivery by the end of October. By early this month, Adimmune had provided 6.95 million doses, while Switzerland-based Novartis had provided 2.02 million (at about NT$400 per dose), out of the government’s purchases of 10 million and 5 million doses respectively.
The government has spent NT$3 billion (US$94.4 million) purchasing vaccines from Adimmune.
The problems begin when looking at the chain of events that led to the awarding of the contract, the US expert said, speaking on condition of anonymity because of the sensitive nature of her position.
As early as May 5, the CDC said that Adimmune, in cooperation with the National Health Research Institutes, would manufacture a domestic influenza vaccine. This was more than a month before a WHO survey of global flu vaccine production capacity on July 7 concluded that countries such as Taiwan that had not placed early orders for the vaccine would not get any vaccine after November.
Adimmune’s chairman is Steve Chan (詹啟賢), deputy secretary-general of the Chinese Nationalist Party (KMT). Chan was also the deputy executive director of President Ma Ying-jeou’s (馬英九) presidential campaign.
For decades a producer of animal vaccines, Adimmune is the only firm in Taiwan with the capacity to produce human vaccines.
Prior to the A(H1N1) contract, it had never produced human vaccines on its own. All it did, the source said, was “package” vaccines made by other, mostly Japanese, companies.
Ho maintained, however, that through close cooperation with Japanese and Dutch vaccine makers, Adimmune “leapfrogged” and obtained the know-how to make human vaccines.
Most vaccine manufacturers, including GSK and Novartis, have decades of experience producing seasonal flu vaccines. While H1N1 is only a variant of the seasonal flu, major manufacturers usually obtain licensure from the US Food and Drug Administration (FDA) to expedite the process based on regulations regarding “strain change.”
Regardless, manufacturers providing H1N1 vaccines to the US have undergone clinical trials, most of which are sponsored by the National Institutes of Health (NIH).
EXPEDITED PROCESS
Adimmune, which had no experience producing the vaccine, should never have been allowed to enter an “expedited process,” the source said.
Adimmune only conducted a small-scale clinical trial with less than 500 subjects, far less than the 5,000 to 6,000 that are usually required for new vaccines.
Ho said that as the vaccine is based on the seasonal flu vaccine, it is not a new vaccine and therefore there was “no point” in conducting more rigorous testing.
The source, however, said that as Adimmune had never produced the seasonal flu vaccine, the Department of Health (DOH) should have demanded the company conduct more clinical trials.
“This is the scientific foundation to claim that a vaccine is ‘safe,’” the source said. “You can’t cut corners on this. Science requires replicability.”
In response, Ho said that, “lack of experience does not jeopardize quality. It just means more costs.”
Adimmune’s chairman has said that clinical trials are a “redundant procedure for bureaucrats,” adding that most Western countries had shortened them to speed up vaccinations.
In other words, despite its lack of experience, the company felt confident it could produce a safe product with few trials, while more experienced manufacturers that also entered an “expedited process” proceeded more cautiously — GSK did 6,340 tests, Novartis did 4,768 and the NIH conducted 3,951, data shows.
(The Novartis version of the vaccine sold to Taiwan is a H5N1 markup with an adjuvant, which was purchased via a special procurement as the adjuvant has yet to be approved in Taiwan.)
WHO guidelines for vaccine manufacturing show that three demo batches of a vaccine, as well as pre-approval inspection, must be completed before a vaccine can be released.
The source said Adimmune finished the clinical study on Oct. 21 and obtained the licensure on Nov. 12. The nationwide vaccine program started on Nov. 15.
“According to the timeline, Adimmune couldn’t have made it in three weeks,” the source said. “This means they mass produced before an approval [license] was granted,” the source said.
Ho confirmed this was the case.
“Adimmune was taking a chance,” Ho said, because if it failed to obtain approval, it would have “to discard all batches that had been produced beforehand.”
“I was among the very few top management team and I was adamant about going ahead to produce the vaccine as at that time, there appeared to [be] no other opportunity to secure H1N1 vaccines for ... Taiwan,” Ho said.
“My intention at the time was that we, the Taiwanese people ... would lose more if there was no H1N1 vaccine at all. Thus, with a certain degree of confidence in what Adimmune could achieve, the risk of failure was deemed slim and we went ahead,” Ho said.
“There was no ethical issue. It was all about regulation and it was OK as long as approval was obtained eventually,” she said.
“Because the approval was based on the inspection and documentation of consistency of three consecutive [vaccine] batches — even though the paperwork was completed later — it was retroactively applicable,” she said.
On Jan. 7, the DOH said autopsies showed that six of 17 deaths possibly related to the vaccine were due to other causes, with investigations continuing on the other 11.
Ho confirmed that all cases involved individuals who had received the Adimmune vaccine, adding that this didn’t mean the vaccine was less safe than Novartis’, as the majority of vaccines administered here were Adimmune’s.
The source also saw problems with the DOH.
ETHICS
“Again and again, DOH officials have sided with Adimmune, something I have never seen in the US,” the source said. “If the commissioner of the [US] FDA, the head of the [US] CDC or the NIH endorsed a certain brand, they not only would be in clear violation of ethics codes, they would be committing political suicide.”
When a legislator asked to monitor the egg production process (influenza vaccines are produced in fertilized chicken eggs), Adimmune said “it’s a commercial secret,” the source said. “Later, when the CDC head [Steve Kuo, 郭旭崧] was asked how the sterility of the eggs was assured, his answer was: ‘Adimmune examined it.’”
“Was there no DOH oversight?” the source asked.
Ho maintains that from the very beginning, the DOH kept a professional distance from Adimmune. There was no dialogue between Adimmune and the CDC, which was responsible for buying the vaccine, she said.
Despite Adimmune’s requests, the DOH also hasn’t allowed it to release clinical test results.
The reason, Ho said, is that “technically speaking, the clinical trial has not been finished.”
The contract stipulates that until then, no information can be disclosed.
“The DOH adamantly opposes disclosure,” Ho said. “That makes me think something is fishy.”
For the source, the vaccine mess is another example of the gambling attitude of the Ma administration, conflict of interest and lack of transparency.
“As a federal government employee with experience in issuing contracts, and as a medical professional, I would say that if the same process occurred in the US, not only would it [make] the headlines in the Washington Post, but criminal investigations would follow,” she said.
For Ho, the problem was poor government communication and media speculation. Chan’s role as chairman also made it easier to politicize the matter, she said.
“Adimmune is more than a private company — it does public health,” she said. “The firm could have gone bankrupt, but everybody worked hard to make it happen in time and provide Taiwan with a vaccine production facility.”
Asked if she’d taken the vaccine, Ho said, “Yes, — Adimmune’s.”
Just as the judicial system will not touch 貓纜和柵湖線, it will not investigate 國光疫苗. 國光疫苗's stench of fraud is just as strong, if not stronger than that of 貓纜和柵湖線:
- 2009-07-13: Adimmune (國光生技), the sole bidder, had won a NT$3 billion (US$94.4 million) government contract to produce 5 million doses of the (A)H1N1 vaccine.
- Adimmune's (國光生技) chairman is Steve Chan (詹啟賢), deputy secretary-general of the Chinese Nationalist Party (KMT). Chan was also the deputy executive director of President Ma Ying-jeou’s (馬英九) presidential campaign.
- “Again and again, DOH officials have sided with Adimmune, something I have never seen in the US,” the source said. “If the commissioner of the [US] FDA, the head of the [US] CDC or the NIH endorsed a certain brand, they not only would be in clear violation of ethics codes, they would be committing political suicide.”
- The source said Adimmune finished the clinical study on Oct. 21 and obtained the licensure on Nov. 12. The nationwide vaccine program started on Nov. 15.
“According to the timeline, Adimmune couldn’t have made it in three weeks,” the source said. “This means they mass produced before an approval [license] was granted,” the source said. - “The DOH adamantly opposes disclosure,” Ho said. “That makes me think something is fishy.”
Taipei Times
Adimmune vaccine: Saving or risking lives?
國光疫苗救命還是害命？
1 月16日的台北時報有一篇由Michael Cole 執筆，針對國光疫苗的報導，報導題為：國光疫苗救命還是害命？(
該報導分別訪問前國光研發執行長長何美鄉及一名美國傳染病專家。
一位美國專家表示國光生技進入H1N1疫苗生產的過程有瑕疵，
2008年6 月13日台灣疾管局宣布疫苗招標由唯一參與競標的國光得標，
問題出在國光得標的過程：
在競標之前，2008年5月5日，
國光董事長不僅是國民黨副秘書長，也是馬英九競選總部的副指揮。
過去國光只有分裝進口的流感疫苗，沒有自己生產。
目前大部分的疫苗廠都有數十年的生產經驗，
快速審查
國光既然未曾生產流感，並不符合快速審查的規定；
何美鄉強調，H1N1不是新疫苗，「完全沒有必要」
美國專家指出，衛生署應該督導堅持該做的人體試驗，
然而何美鄉還是表示：沒有經驗不代表品質不良。
換言之，儘管沒經驗，做的試驗規模小，國光還是很有信心，
根據WHO的規定，疫苗上市前需做三個批次(batch)測試，
國光10月15日完成初步臨床試驗，
何美鄉證實事實如此，表示國光冒了極大風險，
何承認目前17例死亡病例都是注射國光，
然而美國專家認為衛生署有極大問題。
工作倫理
「自始至終，台灣的衛生署一直幫國光講話，假如美國FDA、
當立委質詢胚胎蛋的無菌問題時，疾管局局長的回答是「
衛生署到底有沒有監督？
何美鄉表示，衛生署從一開始就與國光保持距離，並基於合約，
在美國專家的眼中，整個國光疫苗事件就是馬英九政府的賭博心態，
在國光研發執行長何美鄉眼中，問題出在政府溝通不良及媒體煽動，
何美鄉對國光有完全的信心，表示自己也注射了國光H1N1疫苗。
FEATURE: Adimmune vaccine: Saving or risking lives?
By J. Michael ColeSTAFF REPORTER
Saturday, Jan 16, 2010, Page 2 The process through which Taichung County-based biotech company Adimmune Corp came to manufacture its A(H1N1) influenza vaccine was flawed and paved the way for safety concerns that have surrounded the vaccine, a US expert on infectious diseases told the Taipei Times this week.
Ho Mei-shang (何美鄉), a research fellow at Academia Sinica’s Institute of Biomedical Sciences and former director of biotechnology research at Adimmune, disputes this view, however, saying in an interview on Tuesday that the vaccine is safe and that there was nothing wrong with the process.
The Centers for Disease Control (CDC) announced on July 13 that Adimmune, the sole bidder, had won a government contract to produce 5 million doses of the (A)H1N1 vaccine, at NT$199 per dose, for delivery by the end of October. By early this month, Adimmune had provided 6.95 million doses, while Switzerland-based Novartis had provided 2.02 million (at about NT$400 per dose), out of the government’s purchases of 10 million and 5 million doses respectively.
The government has spent NT$3 billion (US$94.4 million) purchasing vaccines from Adimmune.
The problems begin when looking at the chain of events that led to the awarding of the contract, the US expert said, speaking on condition of anonymity because of the sensitive nature of her position.
As early as May 5, the CDC said that Adimmune, in cooperation with the National Health Research Institutes, would manufacture a domestic influenza vaccine. This was more than a month before a WHO survey of global flu vaccine production capacity on July 7 concluded that countries such as Taiwan that had not placed early orders for the vaccine would not get any vaccine after November.
Adimmune’s chairman is Steve Chan (詹啟賢), deputy secretary-general of the Chinese Nationalist Party (KMT). Chan was also the deputy executive director of President Ma Ying-jeou’s (馬英九) presidential campaign.
For decades a producer of animal vaccines, Adimmune is the only firm in Taiwan with the capacity to produce human vaccines.
Prior to the A(H1N1) contract, it had never produced human vaccines on its own. All it did, the source said, was “package” vaccines made by other, mostly Japanese, companies.
Ho maintained, however, that through close cooperation with Japanese and Dutch vaccine makers, Adimmune “leapfrogged” and obtained the know-how to make human vaccines.
Most vaccine manufacturers, including GSK and Novartis, have decades of experience producing seasonal flu vaccines. While H1N1 is only a variant of the seasonal flu, major manufacturers usually obtain licensure from the US Food and Drug Administration (FDA) to expedite the process based on regulations regarding “strain change.”
Regardless, manufacturers providing H1N1 vaccines to the US have undergone clinical trials, most of which are sponsored by the National Institutes of Health (NIH).
EXPEDITED PROCESS
Adimmune, which had no experience producing the vaccine, should never have been allowed to enter an “expedited process,” the source said.
Adimmune only conducted a small-scale clinical trial with less than 500 subjects, far less than the 5,000 to 6,000 that are usually required for new vaccines.
Ho said that as the vaccine is based on the seasonal flu vaccine, it is not a new vaccine and therefore there was “no point” in conducting more rigorous testing.
The source, however, said that as Adimmune had never produced the seasonal flu vaccine, the Department of Health (DOH) should have demanded the company conduct more clinical trials.
“This is the scientific foundation to claim that a vaccine is ‘safe,’” the source said. “You can’t cut corners on this. Science requires replicability.”
In response, Ho said that, “lack of experience does not jeopardize quality. It just means more costs.”
Adimmune’s chairman has said that clinical trials are a “redundant procedure for bureaucrats,” adding that most Western countries had shortened them to speed up vaccinations.
In other words, despite its lack of experience, the company felt confident it could produce a safe product with few trials, while more experienced manufacturers that also entered an “expedited process” proceeded more cautiously — GSK did 6,340 tests, Novartis did 4,768 and the NIH conducted 3,951, data shows.
(The Novartis version of the vaccine sold to Taiwan is a H5N1 markup with an adjuvant, which was purchased via a special procurement as the adjuvant has yet to be approved in Taiwan.)
WHO guidelines for vaccine manufacturing show that three demo batches of a vaccine, as well as pre-approval inspection, must be completed before a vaccine can be released.
The source said Adimmune finished the clinical study on Oct. 21 and obtained the licensure on Nov. 12. The nationwide vaccine program started on Nov. 15.
“According to the timeline, Adimmune couldn’t have made it in three weeks,” the source said. “This means they mass produced before an approval [license] was granted,” the source said.
Ho confirmed this was the case.
“Adimmune was taking a chance,” Ho said, because if it failed to obtain approval, it would have “to discard all batches that had been produced beforehand.”
“I was among the very few top management team and I was adamant about going ahead to produce the vaccine as at that time, there appeared to [be] no other opportunity to secure H1N1 vaccines for ... Taiwan,” Ho said.
“My intention at the time was that we, the Taiwanese people ... would lose more if there was no H1N1 vaccine at all. Thus, with a certain degree of confidence in what Adimmune could achieve, the risk of failure was deemed slim and we went ahead,” Ho said.
“There was no ethical issue. It was all about regulation and it was OK as long as approval was obtained eventually,” she said.
“Because the approval was based on the inspection and documentation of consistency of three consecutive [vaccine] batches — even though the paperwork was completed later — it was retroactively applicable,” she said.
On Jan. 7, the DOH said autopsies showed that six of 17 deaths possibly related to the vaccine were due to other causes, with investigations continuing on the other 11.
Ho confirmed that all cases involved individuals who had received the Adimmune vaccine, adding that this didn’t mean the vaccine was less safe than Novartis’, as the majority of vaccines administered here were Adimmune’s.
The source also saw problems with the DOH.
ETHICS
“Again and again, DOH officials have sided with Adimmune, something I have never seen in the US,” the source said. “If the commissioner of the [US] FDA, the head of the [US] CDC or the NIH endorsed a certain brand, they not only would be in clear violation of ethics codes, they would be committing political suicide.”
When a legislator asked to monitor the egg production process (influenza vaccines are produced in fertilized chicken eggs), Adimmune said “it’s a commercial secret,” the source said. “Later, when the CDC head [Steve Kuo, 郭旭崧] was asked how the sterility of the eggs was assured, his answer was: ‘Adimmune examined it.’”
“Was there no DOH oversight?” the source asked.
Ho maintains that from the very beginning, the DOH kept a professional distance from Adimmune. There was no dialogue between Adimmune and the CDC, which was responsible for buying the vaccine, she said.
Despite Adimmune’s requests, the DOH also hasn’t allowed it to release clinical test results.
The reason, Ho said, is that “technically speaking, the clinical trial has not been finished.”
The contract stipulates that until then, no information can be disclosed.
“The DOH adamantly opposes disclosure,” Ho said. “That makes me think something is fishy.”
For the source, the vaccine mess is another example of the gambling attitude of the Ma administration, conflict of interest and lack of transparency.
“As a federal government employee with experience in issuing contracts, and as a medical professional, I would say that if the same process occurred in the US, not only would it [make] the headlines in the Washington Post, but criminal investigations would follow,” she said.
For Ho, the problem was poor government communication and media speculation. Chan’s role as chairman also made it easier to politicize the matter, she said.
“Adimmune is more than a private company — it does public health,” she said. “The firm could have gone bankrupt, but everybody worked hard to make it happen in time and provide Taiwan with a vaccine production facility.”
Asked if she’d taken the vaccine, Ho said, “Yes, — Adimmune’s.”
Sunday, January 3, 2010
Jerome Keating: prosecutors abuse their power (附加中文翻譯)
中文翻譯 by 洪萱芳
Taiwan's Prosecutors Continue to Abuse Their Power
Friday December 25, by Jerome F. Keating Ph.D.
Taiwan's prosecutors continue to abuse their power in the Chen Shui-bian case as they set out on yet another fishing expedition. They recently announced a fourth round of indictments (22 people) in Chen's case. So far they have called in just about anyone and everyone that ever shook hands with Chen or offered to buy him a cup of coffee.
Why are so many indicted? Despite having kept Chen in jail so long that he cannot prepare a proper defense, the prosecutors do not have a solid case of their own. They need to continue fishing. They need to find someone who they can threaten, bully or cajole to at least forge or fabricate a story to comply with their position. Or they hope by constant indictments to force Chen to bargain with them.
Contrast this abuse of power by prosecutors with three of the most obvious pan-blue cases. First there is the flagrant open and shut case of ex-legislator Diane Lee who illegally ripped Taiwan's taxpayers off of some US$3 million. Lee has never spent a day in jail; Lee still enjoys the money. None of her bank accounts have been frozen. Lee has two passports and can easily skip the country with either one. Yet as she continues to spend the taxpayer's money, Lee's prosecutors are debating whether they should even charge her for anything. Further what about the many members of Lee's family, relations and fellow KMT party who knew of her duplicity. Chen's case is in its fourth round of indictments. Why then have none ever been indicted or even called in for questioning in Lee's case?
Contrast this with the fact that only one person (a lowly secretary) went to jail in the money-laundering case of Ma Ying-jeou. This man went to jail for nine months for putting about a half a million US dollars in Ma's bank account. The mind boggles when the public is asked to believe that one lone secretary is the only perpetrator guilty of all this corruption and not even for his own pocket. Why has Ma been able to funnel money into his personal and private "non-profit" foundation?
Contrast this with James Soong found guilty three times of similar money-laundering and corruption. Yet surprisingly Soong never spent a day in jail and no one else was indicted along with him? Soong only paid back taxes on lesser amounts. In all of this, what of the fact that ironically Soong has never had a job in the past decade.
How does a man without work for over a decade finance two costly political campaigns for the presidency and one for mayor of Taipei? Or were those campaigns also fronts for money laundering? Why has no one else ever been indicted in Soong's cases? Where has Soong gotten all the money for his campaigns, his property in the USA and his numerous bank accounts?
There is no question that a large sum of money has been moved in the Chen case; but large and larger sums of money have always been moved from Taiwan since 1949 when the Chinese Nationalist Party (KMT) fled China. With Taiwan's vague and loose laws on campaign contributions and special allowance funds etc. the issue remains why is it illegal for one person of one party and not for the thousands of others who have consistently done it before and continue to do it. Not only that, the KMT dominated Legislative Yuan has recently floated the idea that they want to change the laws so it can be done legally but this will happen only after they have persecuted Chen. All this is in the name of fighting corruption. Diogenes left town a long time ago.
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