Much ado over an inconsequential arms sale

The US$6 billion arms sale to Taiwan announced by Washington on Friday will not bring much to Taiwan in terms of its ability to defend itself. All the items in the package, with the exception of the 60 UH-60M Black Hawk helicopters, had been long approved — and then delayed — by the George W. Bush administration. In other words, the Taiwanese military is running to stay in place, while China has continued to sprint ahead with the modernization of its military and increased targeting of Taiwan.

None of the items in the package, not even the PAC-3s, will make a substantial difference. Nothing underscores that point more than the fact that the 10 RTM-84L Harpoon missiles and two ATM-84L Harpoon missiles included in the package, which cost US$37 million, are for training purposes only, as they do not come with warheads (they are unarmed variants of the RGM/AGM-84A). What is needed most, and what the US appears unlikely to provide anytime soon, is newer-generation fighter aircraft like F-16C/Ds.

At best, and as I’ve argued before, this was an expression of US commitment to the defense of Taiwan, as per the Taiwan Relations Act (TRA). But it comes short of providing the types of weapon that are necessary to ensure Taiwan’s ability to defend itself in line with the scope of the Chinese threat — also a TRA commitment. And it comes in the wake of another announcement by Washington, made earlier this month, that it had downgraded China as an espionage priority.

Still, despite these shortcomings, Beijing went through the motions and threatened this and that, including the suspension of Sino-American military links and sanctions targeting US companies. In the past, when China had a fit, it was over arms sales that made a concrete difference in the balance of power in the Taiwan Strait. Now, however, it’s in a position where it can throw a fit, and make Washington pause, over practically inconsequential (though still expensive) weapons sales. There are rumors, furthermore, that this could be the first and last arms sale to Taiwan under the Barack Obama administration.

If China can brew such a storm over what is, by all accounts, an arms sale that was meant to please all sides and minimize the damage to Sino-US relations, then the chances of Taiwan getting the weapons it really needs to defend itself look alarmingly slim.

Experts question US intelligence shift on PRC

This article was published today in the Taipei Times. I have included, in italics, sentences or paragraphs that were trimmed for space but that I believe were still relevant. During research for this article, I contacted a number of government agencies (AIT, DHS, the British Home Office, the Taiwanese NSC) for comment, but all refused to say anything. What also struck me was that Bill Gertz's story in the Washington Times didn't seem to have been noticed in Asia, and many academics and government officials (even in the US) whom I interviewed weren't aware that a policy change had occurred.

The Washington Times reported on Jan. 20 that the US National Security Council (NSC) had recently directed its spy agencies to lower the priority placed on intelligence collection for China. The decision, the report said, would downgrade China from “Priority 1” status — which includes countries such as Iran and North Korea — to “Priority 2,” which covers specific humanitarian crises and conflicts like Indo-Pakistani tensions.

The move, the paper wrote, was part of efforts by the administration of US President Barack Obama to “develop a more cooperative relationship with Beijing.”

Amid opposition within the intelligence community and fears that the downgrading would hamper efforts to monitor China's growing military strength and cyber-attack capabilities, the NSC said the change “would not affect the allocation of resources for spying on China or the urgency of focusing on Chinese spying targets.”

While proponents of the new policy maintain that the downgrade would not change anything, critics fear that while not immediate, the repercussions would be felt over time.

“For those who say changing from ‘Priority 1’ to ‘Priority 2’ doesn’t make any difference — well then, why do it? China should be at the top of the priority list, not moving down,” Representative Peter Hoekstra of Michigan, the ranking Republican on the House Permanent Select Committee on Intelligence, was quoted by the Washington Times as saying.

“A change in tier priority usually means that projects targeting a country will be scrutinized more skeptically on budgetary and other grounds,” the paper said. 

Spending on human intelligence and electronic surveillance could also suffer, while the CIA and the US Defense Intelligence Agency could take fewer risks targeting the downgraded country.

Washington's decision allegedly came in the wake of protests by Beijing following the release in September of a National Intelligence Strategy that identified China among the top four threats to US interests alongside Iran, North Korea and Russia.

National Intelligence Director Dennis Blair, whose office released the strategy, as well as CIA Director Leon Panetta, have publicly opposed the downgrading.

The Washington Times also wrote that the announcement was made just as civilian and military leaders were pointing to deficiencies on intelligence collection and analysis on China, which often led to underestimates on Beijing's military and espionage capabilities.

Information obtained by the Taipei Times indicated that the downgrade would not only apply to foreign intelligence collection, such as by the CIA, the NSC and the Defense Intelligence Agency, but also domestically, meaning that the de-prioritization would also affect domestic agencies like the FBI, which handles counterespionage on US territory.

For security experts, the decision made little sense. While some said that better management of finite intelligence resources was desirable and agreed that priority No. 1 for the US intelligence apparatus should be terrorism, it did not mean that resources should be taken away from China.

“Given China's increased missile activity, not to mention the development of anti-satellite and space warfare capability, it does not make sense,” said Wendell Minnick, Asia bureau chief for the Washington-based weekly Defense News. “If there is one weak area for our intelligence collection it is what China is doing in the cyber warfare area. Speculation is rampant, but there are very few hard clues as to how many of the hacker attacks are patriotic netizens or government-sponsored ops,” he said.

For Toshi Yoshihara, associate professor of strategy at the US Naval War College, the main problem with the decision concerned the risk of underestimating China's military modernization.

“Part of the problem are the assumptions that underwrite assessments of the Chinese military,” Yoshihara told the Taipei Times on Tuesday. “In the 1990s, analysts tended to extrapolate how China's military-industrial complex will do in the early 21st century based on its performance in the 1960s and 1970s. Such linear projections, premised as they were on a qualitatively different kind of China, significantly skewed many of the forecasts.

“In this context, we need to learn more, not less, about China's military modernization. We need more data sets that can serve to challenge longstanding assumptions that are deeply ingrained in individuals and institutions,” he said. “Underestimation carries its own risks. If the US or Japan encounters a strategic technical surprise from China, then the risks of overreaction could substantially increase [and] overreaction might involve the kinds of worst-case scenario thinking that would not be conducive to stability.”

The American Institute in Taiwan on Tuesday refused to comment on the decision, saying it did not normally discuss intelligence and defense matters.

The reprioritization also comes at a time when the US has its hands full in Afghanistan and Pakistan, as well as with the North Koran and Iranian nuclear programs, all areas where assistance from China might be welcome.

Gary Schmitt, a US official during the Ronald Reagan administration and now director of advanced strategic studies at the American Enterprise Institute, said this wasn't the first time a US administration had sent political signals through a reassessment in the hope of securing China's cooperation elsewhere.

“At the time [in the 1980s], many in the [Reagan] administration believed that China would be a necessary asset for balancing against the Soviet Union. The thought was that by changing the priority given China for intelligence collection, we would be signaling them that we no longer saw them as an adversary,” he wrote on the Center for Defense Studies Web site.

“Ironically,” Schmitt wrote, “the effort made during the 1980s ... made more sense then than today ... given the fact that the US government is continually surprised by the military advances China is making, how little we really know about what the inner circle of the PRC [People's Republic of China] is thinking and, according to ... report after report by [US] counterintelligence officials, the avalanche of Chinese spying we are attempting to deal with. Downgrading the priority given the PRC as a target will certainly not make those gaps any easier to fill.”

Given the close relationship between US and Taiwanese intelligence and defense agencies, any downgrading of US collection on China could have serious repercussions for Taiwan's ability to monitor developments across the Taiwan Strait and defend itself, especially if intelligence-sharing agreements were undermined as a result.

In August, the British counterintelligence service MI5 said it was “deeply concerned” over an increase in espionage by Chinese operatives in the UK, adding that although intelligence specialists did not know how widespread the problem was, they believed spying was rampant and could have serious repercussions for the global economy.

 

Asked about the impact of Washington’s decision or whether the UK would also reassess the priority it gives to China, the British Home Office, which handles relations with the media for MI5, had no comment.

UDN, Haiti and anti-Americanism (expanded)

In a commentary on Tuesday Jan. 19 on the role of the US in relief efforts in quake-devastated Haiti, the Chinese-language United Daily News went on the offensive on what is claims are signs of US imperialistic ambitions in the impoverished country.

The opening sets the tone for the article: “[A]n international dispute broke out as the Haitian International Airport in Port-au-Prince has been put under the control of the US Armed Forces and the US has prioritized the evacuation of its own citizens,” UDN writes. “Rescue airplanes from around the world have even been refused clearance to land. According to a foreign news report, France has lodged a formal protest to the US Department of State.”

It continues: “The US acting as the world’s sole superpower is nothing new. Given Haiti’s proximity to the US, Washington’s bossy attitude is also no surprise. [US] President [Barack] Obama promptly pledged a donation of US$100 million in relief assistance after the earthquake struck. No other country can match such an enormous donation. However, the US Air Force putting the Haitian airport under its virtual control is a unilateral act too aggressive in the eyes of other nations.”

“The US extends its influence into other countries using not only its military might and economic strengths, but also its pervasive media network. This time, CNN conducted a ‘Quick Vote’ on its website, asking whether the US should accept Haitian immigrants in the earthquake’s aftermath,” it wrote.

The article then incongruously ties US behavior in Haiti and CNN polls with Taiwan: “CNN had also conducted a ‘Quick Vote’ while reporting on the disaster in Taiwan in the aftermath of Typhoon Morakot last August. CNN asked its viewers, ‘Should Taiwan’s leader step down over the slow rescue and relief efforts?’ Such push polling caused quite a stir among the local media in Taiwan when all viewers pointed their fingers at the Ma Ying-jeou administration.”

“However, CNN represents the view of the US, and it has indeed caused a lot of trouble by trying to play a leading role in shaping people’s worldviews […] In the past, China was disliked by western countries just because its national designation, the Middle Kingdom, implied that it was ‘the center of the world.’ Now looking at what the US has been doing in Haiti, the US has seemingly come to regard itself as the true ‘Middle Kingdom,’” it writes.

Nowhere in the commentary does the author ask who will ensure security and stability in Haiti, a country with a long history of political instability and warlordism. The only other military presence in the country, with enough knowledge of the place to actually make a difference to ensure the safety of humanitarian delivery, is Canada, which is already overstretched in Afghanistan and could not deploy anything nearly as sizable — and as rapidly — as the US. No country in the region, not even the Chinese UN contingent, has the means to do this, period.

Was the world supposed to stand by while things fall apart just so as to appear polite? Whoever wrote the commentary clearly had no understanding whatsoever of Haiti’s domestic situation, history, and the need for Civilian-Military cooperation (CIMIC) during humanitarian emergencies (if one country has experience in and has encouraged CIMIC in recent years, it is the US), and chose to look at the deployment through the prism of politics rather than as necessary action that undoubtedly saved hundreds, if not thousands, of lives.

The US was a natural leader to deal with the aftermath of this catastrophe, and it has substantial experience operating in the even-unstable Haiti that goes back to at least former US president George H.W. Bush. In September 1994, then president Bill Clinton ordered the launch of Operation Uphold Democracy, while the UN Security Council passed Resolution 940, which “under Chapter VII of the Charter of the United Nations, authorize[d] Member States to form a multinational force under unified command and control and, in this framework, to use all necessary means [including force] to facilitate the departure from Haiti of the military leadership … and to establish and maintain a secure and stable environment that will permit implementation of the Governors Island Agreement.”

What prompted the US into action then were not imperial designs on the Western hemisphere’s poorest country, but rather fear of instability as thousands of Haitian boat people sought refuge in the US amid rampant political instability, growing violence and abject poverty. Between October 1991 and June 1992, a total of 36,594 Haitian refugees were intercepted (under a program initiated by former US president Ronald Regan) by US special forces as they attempted to flee their country for the US. Between 1994 and 1995, a total of 21,638 Haitians were relocated in camps at Guantanamo Bay, Cuba, and fed, housed and clothed under the US-led Operation Sea Signal.

Then, after the November 2000 elections, which the Haitian opposition boycotted, US and other international forces mandated by the UN once again were deployed to ensure stability, and the situation simmered until 2004, when a rebellion, which resulted in numerous deaths, forced president Jean-Bertrand Aristide to flee the country and brought President Rene Preval to power. Violence continued, however, and again called for the presence of UN peacekeepers and civilian police deployments from other countries.

Given all this, added to the fact that existing socio-political pressures were bound to be exacerbated by the collapse of the central government following the earthquake, accusing the US of seeing itself as the Middle Kingdom, as the piece argues, is invidious.

Discussing the situation in Haiti, Taiwanese rescue teams have said that the situation there is “logistical chaos” — hence the need for foreign troops to supper humanitarian efforts.

As for denying some aircraft to land at the airport in Port-au-Prince, many reports show that the airport is far too small to accommodate the sudden increase in traffic and many countries (not just France) have had to reroute their deliveries to neighboring Dominican Republic, whence humanitarian goods are transported by land across the border. Unlike what UDN alleges, there is no evil plot by the US military to seize the airport.

The article’s criticism of the US prioritizing the evacuation of Americans in Haiti is also unfair. It is the responsibility of every government to ensure the safe passage of their citizens in emergencies. France did that in Rwanda in 1994, for example, just as close to a million Rwanda Tutsi were about to be exterminated, and many countries did the same when Israel invaded Lebanon in 2006.

The parallel with CNN polls, meanwhile, is just risible. Since when does CNN represent “the view of the US,” as the piece argues? At best, CNN represents “a view” among a plurality of contending views. And I doubt that Haitians, who are struggling to rescue (or bury) loves ones and rebuild their lives, sit down at night to have their minds “poisoned” by CNN propaganda, which is what the commentary appears to be saying.

This is strident anti-Americanism pure and simple, something that conservative Chinese Nationalist Party (KMT) members will likely exploit to widen the rift between Taipei and Washington. It should be noted that the English version of the commentary, which sounds ominously like something that would appear in the Beijing-controlled People’s Daily, was carried on the official KMT Web site.

A slightly longer version of this article appeared in the Taipei Times on Jan. 27. Please note that the article erroneously refers to President Preval as Andre Preval, when it should have read Rene.

Adimmune vaccine: Saving or risking lives?

My feature on Adimmune appeared today in the Taipei Times. I have reproduced the entire article here and added (different font) some of the material that was cut for length.

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.

This suggests that even before global capacity was known, the Department of Health (DOH) was already considering domestic production, which in essence means “siding with Adimmune,” the source said.

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 admits that by July, the company had yet to complete the implementation of the automated software necessary for vaccine production.

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.

Eric Althoff, head of global media relations at Novartis International AG, told the Taipei Times on Monday that the company “conducted an extensive clinical program for our H1N1 vaccines with more than 8,500 subjects.”

(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.)

“Adimmune’s expertise is like that of an intern,” the source said. “Novartis, Sanofi and GSK’s experience makes them more like seasoned attending physician. When you need surgery, would you prefer an intern or an attending?”

Ho said that prior to delivery of the vaccine toward the end of October, the DOH’s Food and Drug administration conducted two weeks of tests. The FDA only became officially operational on Jan. 1 this year.

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 fine for disclosing the information to the media? NT$200,000. Though Chan has allegedly said his company should disclose the information and absorb the fine, it has yet to do so.

“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.”

My assessment is that Ho truly believes the Adimmune vaccine is safe. Adimmune Corp, and by extension the DOH all the way up to the Cabinet, saw in the A(H1N1) pandemic a chance to get production started. Real work had begun amid an earlier scare — H5N1 — and this is when Ho was invited to take leave from Academia Sinica to help out at Adimmune. Whether the company was ready to meet that challenge, or whether it cut corners, as the source alleges, to meet this on time, remains to be determined. The DOH’s handling of the controversy, meanwhile, raises age-old issues about the failure of the Chinese Nationalist Party (KMT) to separate the party from the state, and the state from the private sector. Where there should be a clear line between government bodies and private firms, what the Adimmune case presents us with is a firm that is chaired by a senior KMT official, with pressure within the DOH to side with Adimmune, something that, as the source points out, would be inconceivable in other countries. Failure to ensure the independence of all parties involved is the source of the controversy.

Chinese version follows:

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？(FEATURE: Adimmune vaccine: Saving or risking lives?)，對國光與衛生署之間的互動，以及疫苗合約簽訂的過程有詳盡的報導，揭示了許多問題。

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。報導節譯如下：

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，造成日後的安全問題。何美鄉反對這種說法，她說疫苗安全，過程也沒有問題。

2009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，將生產H1N1疫苗。台灣政府總共花了三十億台幣購買國光疫苗。

問題出在國光得標的過程：

在競標之前，2009年5月5日，台灣疾管局就已經宣稱國光將為台灣製造H1N1疫苗。同一時間世衛組織為因應可能的全球大流行，詢問各國疫苗的需要量及廠商的製造量。一個多月後世衛組織公布，台灣沒有並沒有訂購疫苗。

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。然而何美鄉強調，有了日本及荷蘭的技術指導，國光技術三級跳(leapfrogged)，知道如何生產疫苗。

目前大部分的疫苗廠都有數十年的生產經驗，雖然H1N1只是流感的一個變異種，美國食品及藥物管理局是依「病毒株改變」的規定快速審查通過H1N1的許可證，但這些有經驗的廠商還是不敢掉以輕心，都做了大規模的人體試驗。

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；國光只做了不到五百人的臨床試驗，有經驗符合快速審查的疫苗廠則做了好幾千人。

何美鄉強調，H1N1不是新疫苗，「完全沒有必要」做更嚴謹的人體試驗。

美國專家指出，衛生署應該督導堅持該做的人體試驗，因為這是確認疫苗安全性的科學基礎。

然而何美鄉還是表示：沒有經驗不代表品質不良。國光董事長曾說臨床試驗是「繁文縟節」。

換言之，儘管沒經驗，做的試驗規模小，國光還是很有信心，認為他們的產品很安全，跟有經驗，做過大型測試的廠牌一樣好：GSK測試了6,340 人，諾華測試了4,768人。

根據WHO的規定，疫苗上市前需做三個批次(batch)測試，檢驗合格後才能使用。

國光10月15日完成初步臨床試驗，11月12日拿到衛生署許可，11月15日就開始大量施打，照WHO的時程推算，國光在拿到許可證之前就已經大量生產。

何美鄉證實事實如此，表示國光冒了極大風險，萬一許可證沒有下來，所有的投資通通付諸流水。何強調國光是為了照顧國人健康，「有疫苗用總比什麼都沒有好」，認為這沒有違反任何工作倫理的規範。

何承認目前17例死亡病例都是注射國光，但她表示這並不代表國光比諾華不安全。

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、NIH、CDC的領導者公然為某一特定廠牌背書，不僅明顯違反了工作倫理的規範，也形同是政治生涯的自殺。」美國專家如此表示。

當立委質詢胚胎蛋的無菌問題時，疾管局局長的回答是「國光有檢查」

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，在臨床試驗未完成之前阻止國光公布結果，一切都合法。

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，利益輸送，完全不公開透明。「作為一個有訂定合約經驗的聯邦政府雇員及醫療專業人士，我敢說，同樣的過程如果發生在美國，不僅是媒體頭條，檢調單位也會徹查刑責。」

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，「國光不是一般的私人公司，國光是為台灣的公共衛生努力。本來快倒閉了，為了H1N1全員投入。只為台灣人的健康」

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

Democracy in Peril at Page 101

The kind lady in charge of merchandise at the Page One bookstore in Taipei 101 just informed me that the store has finally received copies of my book Democracy in Peril: Taiwan's struggle from Chen Shui-bian to Ma Ying-jeou. For readers in Taiwan who have been waiting to grab a copy, here's your chance. As it is a "new" release, the book is currently 20% off, and right next to a new biography of Madame CKS!

PRC students: a blessing in disguise

The decision by the Ma Ying-jeou (馬英九) administration to allow Chinese to study in Taiwan has understandably given rise to apprehensions about the impact this will have on the country. Some, including the Democratic Progressive Party (DPP), have argued that an influx of Chinese students could have a negative effect on Taiwanese youth’s chances of finding a job, while others caution, if perhaps speculatively, that this could increase the threat of espionage by so-called “professional students.” The policy also raises questions about recognizing Chinese diplomas, the credibility of which is often disputed.

Though these fears are not without basis, the presence of Chinese students on Taiwanese campuses could also bear fruit — in unexpected ways. As only about 2,000 Chinese students, or 1 percent of the total number of applicants, will initially be allowed to enroll in Taiwanese colleges and universities, the benefits will not be financial, nor will the impact on the quality of students admitted into university be substantial.

Rather, the real upswing will lie in the opportunities for contact between young Taiwanese and Chinese — in many ways a first in Taiwan. As I argued previously in “The risks of opening to Chinese students” (Taipei Times, Nov. 24, page 8), the fact that the first wave of Chinese students will come from 41 top Chinese universities, added to the rigorous screening process that Chinese students will have to undergo before they are allowed to come to Taiwan, means that the majority of them will be toeing the Beijing line on the Taiwan question (students who are easily influenced by “thought pollution,” or who are not from families associated with the Chinese Communist Party, are unlikely to make it to Taiwan, lest their minds be warped by democratic and liberal ideas).

My op-ed, published today in the Taipei Times, continues here.

In beef debacle, Su Chi emerges as main villain

The US beef debacle has opened yet another door for the Democratic Progressive Party (DPP) in its claim that the Ma Ying-jeou (馬英九) administration is incapable of good governance. Following its poor handling of the devastation brought by Typhoon Morakot in August and safety concerns surrounding the swine flu vaccination program, the Cabinet’s decision to partially lift a longstanding ban on US beef imports — followed by its about-face amid growing opposition to the deal, which had been negotiated away from the public eye — has handed the DPP a political gift on a gold platter.

The inept handling of the beef issue has led many to question whether Ma has surrounded himself with officials who are either incapable of providing good advice on political matters, or who knew the unilateral decision would cause a fracas, but chose to proceed nonetheless. The first explanation points to ghastly incompetence in the Cabinet, while the latter hints at efforts by more conservative elements both within the administration and outside it — but still within the pan-blue camp — to throw a wrench in US-Taiwan relations and thereby consolidate Taiwan’s drift into the Chinese sphere of influence.

In either scenario, one government official stands out as the source of the political faux pas: National Security Council Secretary-General Su Chi (蘇起).

My analysis piece, published today in the Taipei Times, continues here.

Odd question on a rainy day

Had the one day off today. On my way to an afternoon fueled by coffee and idiosyncratic music at Kafka on the Shore near National Taiwan University, I stopped at the neighborhood Eslite bookstore, hoping to grab a book on the history of the battle of Kinmen (Quemoy) published by the Ministry of National Defense. As I couldn’t find it, I went to the information desk and asked the lady behind the counter to locate it for me. It turns out they were out of stock.

Two things, however, stand out from the brief conversation that we had. First, she had never heard of said battle, admitting that she was rather thin on her Taiwanese history. Then, as I was paying for another book I had decided to acquire — Chang Sun Kang-i’s Journey Through the White Terror: A Daughter’s Memoir — she asked me where I was from. Canada, I told her. Odd, she said. Why, as a foreigner, would I be interested in Taiwanese history? Because I want to learn as much as I can about Taiwan, I replied. But, Taiwan is practically China, so why learn about Taiwan? No they’re not, I replied. They’re two separate countries. But why the interest? Because I am a journalist in Taiwan and it is part of my job to acquaint myself with my subject. She shook her head, took the NT$250 for the book, and mumbled something about their difficult position, or something like that, whatever that meant.

An employee in a bookstore across from Taiwan’s foremost institution of higher education. Hum. I crossed the street and went to Kafka on the Shore, where I sat myself in a comfortable corner, ordered a coffee and cracked open a book on politics and change in Hong Kong and Singapore. Thankfully, the waiter didn’t ask me why in hell I was reading about Hong Kong and Singapore.

APAC 2020: Taiwan snapshot

Australian magazine The Diplomat published its APAC 2020: The Decade Ahead report today, which brought together a series of academics and journalists in an attempt to descry the future of the region through snapshots and feature articles. The magazine kindly invited me to provide a 10-year forecast for Taiwan, which appears below. The whole package is worth reading, as it includes informative pieces by the likes of Minxin Pei on China, Robert Sutter on the US’ declining influence in the region, and Toshi Yoshihara on the next Asian arms race, among others.

The next decade will be marked by much uncertainty about Taiwanese sovereignty. After sixty years of ‘status quo’ in the Taiwan Strait, Taiwan under President Ma Ying-jeou is seen by many as drifting into China’s sphere of influence. The Hong Kong-born Ma took office in 2008 vowing to improve relations with Beijing, and has done so by signing various cross-strait pacts, including a possible economic cooperation framework agreement in early 2010.

Amid these rapid changes, Ma’s opponents fear that he is causing irreparable damage to Taiwan’s sovereignty by increasing the nation’s dependence on China, which could have political implications — something that Beijing has made no effort to conceal.

Taiwan’s opposition Democratic Progressive Party argues that negotiations between Ma’s administration and the Chinese Communist Party lack transparency, that the legislature has been sidelined and that public apprehensions about the political and economic impacts of rapprochement have been ignored. As rumors of a ‘peace treaty’ and a possible Ma-Hu Jintao meeting in 2011 intensify, domestic opposition to Ma’s China policies is rising and risks boiling over.

With Hu stepping down in 2012 and Taiwan holding presidential elections the same year, Beijing could apply pressure for a quick political settlement, which would severely undermine Ma’s credibility vis-à-vis a Taiwanese polity that largely favors the status quo and increasingly identifies itself as Taiwanese first, Chinese second. If Ma is re-elected, we can expect moves toward unification, accompanied by an erosion of freedoms and liberties. If the pro-independence DPP stages a comeback, Beijing could show its impatience by using its military to settle the matter, or exploit its growing economic and political clout to isolate the island.

Despite ‘warmer’ ties, Taiwan’s ability to defend itself has suffered from delays in US weapons deliveries and Washington’s refusal to sell pre-approved items such as advanced F-16s, and military analysts warn that the balance of power in the Taiwan Strait has shifted in Beijing’s favor.

Whether Beijing and Washington become ‘strategic allies’ or competitors in the next ten years, and whether the US remains committed to defending Taiwan, will have a decisive impact on how this plays out.