A brief history of Taiwan； "Newswires don't tell the full story"

There was a report of Associated Press stating that, "Taiwan split from China amid a civil war".  This is not an accurate description of the history.   It is regrettable AP reporters refuse to correct the error.  Taiwan was never a part of China that was established in 1911.  Therefore, Taiwan never did "split from China amid a civil war".  Taiwan was never involved "in a civil war with Mao's communist army in China" ! 

This is the brief history of Taiwan:

 1.      Taiwan had been a colony of Japan since the defeat of Ching Dynasty of China in a Sino-Japanese war, according to the peace Treaty of Shimonoseki  馬關條約 (1895).  Prior to this war, Taiwan was loosely administered by Ching Dynasty of China as a province only for 8 years.

2.      Following the 1945 Japanese defeat in the WWII, Japan “gave up” Taiwan according to the San Francisco Peace Treaty 舊金山和約 (Sept, 8, 1951).

3.      However, after the war, the commander of the US Army Forces of Far East, Douglas MacArthur, ordered Nationalist Party (KMT國民黨) Chiang Kai-Shek蔣介石 to take a foothold in Taiwan in 1947.

4.      Chiang brought his ragtag soldiers that was so corrupt and utterly defeated by Mao’s communist army to the island and formed a government-in-exile, Republic of China (ROC) in Taiwan, claiming the island to be a part of China and exercised the martial law for more than 35 years, the longest known in the world’s history.

5. In 1955, U.S. Secretary of State John Foster Dulles, co-author of the Peace Treaty, affirmed that the treaty ceded Taiwan to no one; that Japan "merely renounced sovereignty over Taiwan".

6.      Taiwan elected its first Taiwanese president, Lee Teng-hui 李登輝, in 1988, who stated that Taiwan and China is a “special country-to-country relations”.

7.      Lee was followed by another Taiwanese, elected president Chen Shui-bian陳水扁 in 2000, who emphasized Taiwanese identity and sovereignty.

8.      Current Ma Ing-jeou馬英九, a KMT, whose father was a Chinese, took office in 2008, and then made known his position that "Taiwan is a part of China" after the election, as China demanded, despite 90% of the islanders wishing to be either independent or remain status quo, a de facto independence for fear of Chinese attack.

9. At present, the Taiwan's democracy is protected by the US Congress' Taiwan Relations Act (1979), and Six Assurances (1982).

The following is an article in Taipei Times in 2005:

Newswires don't tell the full story

By Gerrit van der Wees /

Thu, Jan 06, 2005 - Page 8

The international newswires generally present the facts as they happen. They pick out the essential news items, describe them in a brief and easy-to-read text, and send them out into the world.

However, every once in a while there is a text that is repeated so often by the newswires that the general public starts to accept it as a "fact," whether it is fiction or not.

There is a sentence that reappears in virtually every single article by AP, AFP or Reuters about Taiwan and China, which seems to be accepted as a "fact" these days. The sentence generally goes as follows: "Taiwan split away from China in 1949 after the Chinese Civil War. Beijing still sees the island as part of its territory, to be reunited by force, if necessary."

This sentence conjures up the image that, in the mid-1940s, Taiwan was somehow part of China, and that it left the fold. In this picture, it makes it sound right and reasonable for China to "want it back."

The reality is a bit more complex: In 1895 Taiwan was ceded to Japan in perpetuity, and through 1945 it was a Japanese colony. The history before 1895 was even more complex, but suffice it to say that the Chinese emperors never gave Taiwan a thought, and hardly ever had any administrative control over it until 1887, when the Manchus briefly made it a Chinese province, which it was for a mere eight years.

In the 1920s and 1930s, the Chinese Nationalist Party (KMT) and the Chinese Communist Party (CCP) were battling each other in China, and neither cared much about Taiwan, which was under Japanese control. Records show that the CCP, the predecessors of the present authorities in Beijing, supported Taiwan's independence from Japan. Mao Zedong (毛澤東) even said so himself, to American author Edgar Snow.

The picture started to change in 1942-1943, during the run-up to the Cairo Conference, when Chiang Kai-shek (蔣介石) claimed that Taiwan should be "returned" to his Nationalist regime headquartered in Nanking. Not to be outdone, the CCP began claiming that it should be returned to them.

After the end of the war and the capitulation of Japan, the commander of the Allied forces, General Douglas MacArthur, authorized a temporary occupation of Taiwan by the KMT.

In the meantime, the civil war in China erupted again, in 1949. Chiang and his government and remaining troops had to flee to Taiwan, and the occupation was not so temporary anymore. The facts show that Taiwan did not "split off" from China, but was occupied by the losing side of the Chinese Civil War -- an essential difference.

It is also essential to point out that Taiwan was never -- even for one day -- in its history a part of the People's Republic of China. It is thus fallacious to say that it somehow should be "reunified" with China.

It is of course common knowledge that the KMT authorities during their 40 odd years of martial law pursued the "unification" of China under their rule, but as the decades passed, this became less feasible or realistic. Unfortunately, from an international perspective, their pursuit became synonymous with "Taiwan," but the difference is essential.

After the Taiwanese people brought about their momentous transition to democracy in the late 1980s and early 1990s, the rest of the world should have adjusted its policy towards the nation. The old and anachronistic "one China" policy was devised in response to a situation in which two governments, the KMT and the CCP, each claimed to represent China.

This has changed: There is indeed one government -- in Beijing -- representing China. But in Taiwan there is no longer a regime claiming to be the legitimate government of China, but a democratic government, representing the people of Taiwan.

An overwhelming majority of the people in Taiwan, whether pan-blue or pan-green, are proud of their country, want to preserve their hard-won freedom and democracy, and would like their country to be accepted as a full and equal member of the international family of nations.

All this is of course a bit long for the newswires to put in their reports. But they could stick a bit closer to the facts by including something along the following lines: Taiwan was a Japanese colony until 1945, after which it was occupied by Chiang's KMT -- the losing side of the Chinese civil war. It made a momentous transition to democracy in the early 1990s.

Beijing sees the democratic nation of 23 million as a part of Chinese territory. The Taiwanese, on the other hand, want to preserve their hard-won freedom and democracy. This is a more complete and accurate picture of Taiwan's complex history.

Gerrit van der Wees is editor of Taiwan Communique.

Published on Taipei Times :

http://www.taipeitimes.com/News/editorials/archives/2005/01/06/2003218258

KMT的本質，DPP的水準

[讀了以下這些文章，只能感嘆。

KMT的本質從來沒變，用龐大黨產拉攏勢利眼的無恥國人，吃定老實的台灣人，視法治系統為KMT囊中物。

可是DPP啊，可真沒想到多年來期待他們有些作為的這些人，水準如此的低。看不出事情的大小輕重，據說內鬥還是會牽制他們的活動。總統選舉的勝棋玩到變輸棋，  一輸，連原則都要丟棄! 

看來還是要用心支持台聯 TSU!  起碼，他們會維護台灣人的尊嚴吧?!]

 

司法自宮落跑成功

緊跟著劉松藩、陳由豪、王玉雲、曾正仁、何智輝等人的步伐，在馬英九連任之後，羅福助跑了、江連福跑了，接下來保證還有判刑定讞的權貴準備落跑，而且在「審判」和「執行」已然切割，司法體系被自己人自斷手腳的情況下，落跑會成功。

理論上，司法是維護正義的最後一道防線；但在台灣，威權時期的司法是統治者的工具，辦大官要大證據，辦小官要小證據，辦小百姓未必要證據。權貴碰到司法還「可大可小」，聽話者，案情可以雲淡風輕，不聽話，刑期讓你烏雲蔽日。

解嚴後的司法，受制於僵化的審檢分隸體系，以及趨勢媚俗的政治流氣，司法首長的位子，成為統治者的恩賜，司法首長往往必須攀附於統治者的權勢之門，導致司法改革原地踏步，遲遲無法樹立應有的尊嚴。

羅福助跑了、接著江連福跑了，誰該負責？問法官，法官一推了事。問檢察官，檢察官一臉無辜。問警察，警察一無所知。擁有強大公權力，可以行使強制處分權，支領人民納稅錢的法官和檢警，每一個都成了被害者，國家只好蒙塵！司法只好蒙羞！

「不負責」和「切割」竟成了台灣司法實務的最高指導原則。審判定讞了，法官說，管他被告在哪裡！檢察官說，無權自行羈押被告呀！警察說，我去過被告家，他不在家啊！這就是馬英九主政之下司法檢察體系的運作模式。

說的也是，反正死刑定讞都不必執行了，跑掉幾個失意政客，有啥關係。

民進黨高興什麼？道歉！

◎ 李建志

馬英九沒有連任壓力，所以第二任還沒開始，就大搞特搞亂搞，不管是油電雙漲（卻不先整飭國營事業的浪費與無效率）、人民變窮（物價大漲人民實質薪資退回十四年前水準）、開放美國瘦肉精毒牛肉進口（連多名國民黨立委都拒絕護航）、復徵證所稅（沒考慮投資人一頭牛被剝兩層皮）…，惡行可說罄竹難書。因此，鹿港鎮長補選國民黨籍候選人大敗，可說理所當然。但是，民進黨有什麼好高興的？

鹿港小鎮很有名，但是鹿港鎮長終究只是一個鎮長，他擋得住會危害全台灣人的美國毒牛肉嗎？民進黨黨主席可以說鹿港鎮長補選重要，然而民進黨立委不在立法院認真議事、參與表決、捍衛民眾健康權益，卻跑到鹿港助選，說得過去嗎？缺席的邱議瑩因為罹患卵巢癌需要化療，情有可原；但是許添財的理由說得過去嗎？到鹿港助選重要？還是幫全台灣人擋住毒牛肉重要？同樣的問題，也要問總召柯建銘，許添財是老台南，他去彰化鹿港助選能拉幾票？他助選那麼重要嗎？你准他請假導致擋美牛表決功敗垂成，緩急輕重不分，你們兩個人是不是該向所有支持民進黨的人道歉？

民進黨頭人的不分輕重緩急，這只是一例；像總統大選輸了，有些人就像沒頭蒼蠅一樣，什麼要了解中國、接觸中國的兩光話都當作反攻大陸口號一樣在喊！神經病！彭明敏說得好，不是不了解，是不相同，是不喜歡！不是不接觸，是拒絕把放棄台灣主權當作前提的接觸！

贏了鹿港，是本來就該贏，因為國民黨候選人新人很嫩，因為國民黨馬政府很爛，輸到脫褲是活該！但是牛肉表決卻是該贏未贏，愧對我們這些非鹿港籍的全國選民付託！請問民進黨，憑什麼得意？

陳菊不道歉，許添財、柯建銘總該道歉吧？

（作者從事金融服務業，新北市民）

高興？ 看看馬英九這天在做什麼？

◎ 朱達明

總統大選後，民進黨在彰化花壇鄉和鹿港鎮補選接連獲勝，馬英九常說勝選高興一個晚上就夠了，如果我們回顧二○○八年以來的歷史，綠營一個晚上都高興不了。

二○○八年以來馬施政早讓民怨沸騰，所有賄選當選無效所造成的補選，民進黨幾乎都輕騎過關，連帶讓鄉鎮市級補選民進黨大有斬獲，也掀起蔡英文的「小英旋風」。可是，越是大型選舉，中國因素介入越深，從二○○九年縣市長選舉國民黨丟掉宜蘭後，接著馬英九就蠻幹簽下ＥＣＦＡ，在五都選舉藍營保住三都，此後就算有鄉鎮市級的補選，國民黨也勝多敗少，一路贏到總統連任政權保衛戰。

鹿港鎮長補選這天，馬英九在乎選舉結果嗎？他先參加閩南文化論壇，又參加兩岸青年對話，宣示要放寬對陸生的三限六不，加上一國兩區的框架已經確立，馬亟欲追求所謂歷史地位和化獨漸統，台灣人真要剉咧等了，民進黨高興得起來嗎？（作者為宜蘭縣民，社會服務業）

 

翻了五倍多的意義

二萬二千二百七十五比九千零四十八，鹿港鎮長補選的結果，民進黨的黃振彥大勝中國國民黨的蔡明忠。

其實不必等投票日，勝負已經可以預卜。值得參考與分析的是，勝負差距的票數所蘊涵的意義。

二○一二大選，在鹿港鎮，蔡英文贏了馬英九兩千三百多票，不過兩個多月，差距已拉大到一萬三千多票了，也就是說，民進黨幾乎再多贏了一萬多票，翻了不止五倍。這個像幾何級數般成長的數字，才是重點；否則，一個鎮長的輸贏有什麼了不起的重要性？

為什麼說可以預卜？國民黨在投票前一天表示，目前呈五五波，而且表示，只要投票率高，國民黨贏面就大；這是蔣政權式「強自莊敬」的自我安慰話，比較開票數就知道全是一派胡言。國民黨必敗，出在馬英九身上；蔡英文贏馬英九二千三百多票當然是指標之一，但投票前，地方要馬英九、吳敦義麥擱來，更顯示馬吳的票房毒藥已到見血封喉的地步。馬英九下令全力「搶」救以及彰化縣長卓伯源呼籲「戰到最後一秒」，可見敗象全露，甚至國民黨也為敗選先寫下敗因：大環境不好、油電雙漲，正是怪罪馬英九的無能。

國民黨輸得那麼慘，當然是對馬英九的不信任投票。再回看新台灣智庫與台灣智庫所做的民調，早已透顯了。可憐的是，總統府一再出言反駁，以為用語言就可取消真實，鹿港補選就是答案。

鹿港鎮長補選，民進黨強調是給馬英九教訓。至於媒體，說法紛陳，有說是「檢驗馬政府執政滿意度」（《自由》），有說是「大選延長賽」（《蘋果》），有說是「大選後政策、民心的風向球」（《中時》），有說是「觀察馬政府聲望的一次投票」（《聯合》）。無論哪一種看法，都對，都是搧「他，馬的」耳光。

現在還可預見的是，對執政黨而言，鹿港補選的慘敗，給五二○就職典禮佈上了陰霾，也為往後四年拉出慘澹的帷幕；對民進黨而言，為罷免藍委試溫，也為二○一四年「七合一」選舉舖了坦途。

馬英九的大敗，自是咎由自取。問題是，台灣人任由這樣無能的人橫行八年，不僅可悲，而且可恥。

（作者金恒煒，政治評論員）

改變了醫療標準步驟的過去失誤

 

10 Medical
Errors That Changed the Standard of Care

We learn most from our painful mistakes. Mistakes can injure
patients and land physicians in legal and professional trouble. Studying these
mistakes and learning how to prevent, monitor, and respond to them, however,
has changed the standards of care. By working to eliminate common medical
errors, physicians can protect patients, protect themselves from lawsuits, and
help lower the cost of their professional liability insurance premiums.

In 1910, when Abraham Flexner researched the state of US
medical education, only 16 of the existing 155 medical schools required more
than a high school education for admission. Germ theory was still disputed.

The practice of medicine in the United States is now much
more standardized, thanks in large part to changes to standardization of the
qualifying examinations for US-trained physicians and to medical malpractice
law.

Today's standards of care are now mostly based on scientific
evidence. In the past 20 years, courts have held physicians and hospitals to
national standards of care rather than accepting local variations in the
practice of medicine.

In 1976, Dr. Jim Styner, an orthopedic surgeon, crashed his
small plane into a cornfield in Nebraska, sustaining serious injuries. His wife
was killed, and 3 of their 4 children were critically injured. At the local
hospital, the care that he and his children received was inadequate, even by
standards in those days. "When I can provide better care in the field with
limited resources than what my children and I received at the primary care
facility, there is something wrong with the system, and the system has to be
changed," Dr. Styner said.

His family's tragedy and the medical mistakes that followed
gave birth to Advanced Trauma Life Support (ATLS) and changed the
standard of care in the first hour after trauma.

Dr. Styner helped produce the initial ATLS course. In
1980, the American College of Surgeons Committee on Trauma adopted ATLS and
began disseminating the course worldwide. It has become the standard for
trauma care in US emergency departments and advanced paramedical services.
The Society of Trauma Nurses and National Association of Emergency Medical
Technicians have developed similar programs based on ATLS.

Judy was 39 years old when she went to the hospital for a
hysterectomy. After she died on the operating table, autopsy revealed that the anesthesiologist
had placed the endotracheal tube in her esophagus, not her trachea.

Today, anesthesiologists measure a patient's carbon dioxide
levels -- which are much higher from the trachea than from the esophagus --
through use of an end-tidal carbon dioxide monitor.

In 1982, ABC's 20/20 ran a segment titled "The
Deep Sleep: 6000 Will Die or Suffer Brain Damage." This program
highlighted several cases of medical mishaps that resulted in serious injury or
death. The American Society of Anesthesiologists responded with a program to
standardize anesthesia care and patient monitoring and in 1985 created the Anesthesia
Patient Safety Foundation.

Standard practices now include the use of pulse oximetry
and end-tidal carbon dioxide monitoring for anesthetized patients. The new
standards have markedly reduced the frequency of anoxic brain injury and other
major complications. The push for electronic monitoring systems for patients
under anesthesia caused anesthesia-related deaths to plummet from about 1 in
10,000 to 1 in 200,000 in less than 2 years.

Sally and Ed looked forward to the birth of their first
child. Sally's labor was long, so her obstetrician added oxytocin to speed
things up. Unfortunately, administration of oxytocin led to unrecognized fetal
distress, and their newborn daughter suffered severe brain injury and cerebral
palsy.

Fetal monitoring to test both uterine contractions and fetal
heart rate (FHR) is now the standard of care, with a 30-minute response time
from recognition of fetal distress to delivery. The purpose of FHR monitoring is to follow the status of
the fetus during labor so that clinicians can intervene if there is evidence of
fetal distress, as reflected by an FHR above or below the normal range of
110-160 beats/min or an FHR that does not change in response to uterine
contractions.

Electronic fetal monitoring (EFM), also called FHR
monitoring, was first developed in the 1960s. Since 1980, the use of EFM has
grown dramatically, from being used on 45% of pregnant women in labor to 85% in
2002, according to the American Congress
of Obstetricians and Gynecologists (ACOG). "When EFM is used during labor,
the nurse or physicians should review it frequently," state ACOG
guidelines.

Bill had a seizure and crashed his car into a tree, crushing
both legs. Arteriography revealed that his right leg was salvageable but his
left leg was not. Unfortunately, the x-ray technician mislabeled the films,
mixing left for right, and the orthopedic surgeon first amputated Bill's right
leg.

Preventing wrong-site surgery became one of the main safety
goals of the Joint Commission for Accreditation of Healthcare Organizations
(JCAHO). Establishing protocols became an
accreditation requirement for hospitals, ambulatory surgery centers, and
office-based surgery sites.

JCAHO mandates standardization of preoperative procedures to
verify that the correct surgery is performed on the correct patient and at the
correct site. Guidelines include marking the surgical site, involving the
patient in the marking process, and having all members of the surgical team
double-check information in the operating room.

Despite these efforts, wrong-site surgery occurs about 40
times a week nationwide, a JCAHO survey found.
The biggest pitfall is inadequate
information about the patient. The solution is a carefully standardized
method of collecting information.

Tom was 12 years old when his appendix burst and he was
taken to the local pediatric hospital. Three days after the appendectomy, he
developed another high fever. One week later, the surgeon performed a second
procedure and found that a surgical sponge had been left inside.

Postoperative sponge and instrument counts have been routine
for decades. There is no single standard,
although nursing and surgical organizations have developed best practices for
sponge, needle, and instrument counts.

Different ways of counting sponges may be used in the same
operating room even during the same case,
says the Association of Operating Room Nurses. This lack of standardized
practice creates opportunities for errors.

A US Department of Health and Human Services study says that
this type of mistake occurs in 1 in 100 to 1 in 5000 persons. A 2008 study
published in Annals of Surgery found that mistakes in tool and sponge
counts happened in 12.5% of surgeries.

Nursing and surgical groups recommend that each member of
the surgical team play an equal role in assuring accuracy of the counts.
Recently, manufacturers have made sponges with threads visible on x-rays,
radiofrequency identification systems, and bar coding to alert staff about
missing sponges.

As a young child, Betty had been given penicillin, turned
blue, and was rushed to the hospital. She was 15 when she got strep throat, was
given penicillin, and died. No one had asked her about medication allergies.

Medical
questionnaire forms have always included a space for allergies, although this
became much more prominent after the Institute of Medicine report on patient
safety in 1999.

In 2008, the Pennsylvania Patient Safety Advisory cited more
than 3800 cases in which patients received medications to which they had
documented allergies. Breakdowns in communication of
allergy information include "documentation of patients' allergies on paper
but not entered into the organization's computerized order-entry systems, and
allergies arising during episodes of care but not documented in the medical
record or communicated to appropriate staff."

Strategies to address the problem include adding visible prompts in consistent and
prominent locations listing patient allergies, eliminating the practice
of writing drug allergens on allergy arm bracelets, and making the allergy
reaction selection a mandatory entry in the organization's order-entry systems.

Linda wasn't doing well in her first trimester. The nausea
and vomiting left her severely dehydrated and with a low potassium level. In
the emergency department, her nurse made a mathematical error and
administered too much intravenous potassium. Within an hour, Linda was dead.

In the 1980s and 1990s, patient safety groups, including
JCAHO, drew attention to the need for removal of concentrated potassium
chloride vials from patient care areas. Now, almost all US hospitals have
removed the drug from floor stock on patient care units. Potassium is now added
to IVs by the manufacturer and is labeled.

The tragic errors that gave rise to this system change were caused
by deficits in knowledge about the dangers of rapid intravenous administration
of concentrated potassium or, more often, mental slips or selection errors when
grabbing a vial of medication. Limiting access to this drug has reduced fatal
errors.

Additional safety strategies include using premixed
solutions, segregating potassium from other drugs and using warning labels,
prohibiting the dispensing of vials for individual patients, and performing
double-checks with a pharmacist.

Frank was 72 years old when he broke his right leg in a car
accident and had to recover for a few weeks in a rehabilitation facility. The
nurses didn't know that patients needed to move regularly, and Frank developed
deep decubitus (pressure) ulcers. When these became infected, Frank's leg had
to be amputated.

Each year, more than 2.5 million people in the United States
develop pressure ulcers, notes the Agency for Healthcare Research and Quality.
Bedsores can be fatal. The Centers for Medicare &
Medicaid Services no longer provide additional reimbursement to hospitals to
care for a patient who acquires a pressure ulcer while under the hospital's
care.

The primary way to prevent decubitus ulcers is by turning
the patient regularly, usually at least every 2 hours. Efforts to relieve
pressure to avoid additional sores by moving the patient have been documented
since at least the 19th century.

Nursing homes and hospitals now have programs to avoid
development of bedsores by using a set timeframe to reduce pressure and having
dry sheets by using catheters or impermeable dressing. Pressure shifting on a regular basis and the use of
pressure-distributive mattresses are now common practices.

Lillian was 68 years old and weighed 250 lb when she
underwent surgery to remove her gallbladder. The second day after surgery, she
needed help to walk to the bathroom. Lillian's nurse, Millie, wasn't strong
enough to support her and they both fell, breaking Millie's right arm and
Lillian's left leg.

Historically, schools of nursing have taught students to
manually lift patients using proper body mechanics, such as lifting with the
legs and using correct posture. However, body mechanics are not sufficient to
protect nurses from heavy weights, awkward postures, and the repetition
involved in manually lifting patients, according to a position paper from the
American Nurses Association (ANA).

The ANA supports policies that eliminate manual patient
lifting. Safe patient-handling techniques involve the use of such equipment as
full-body slings, stand-assist lifts, lateral transfer devices, and
friction-reducing devices.

There is no federal legislation or regulation on safe
patient handling, although several states have enacted such legislation, ANA
says.

When Christy was 42 years old, her doctor discovered a large
lump in her left breast. The lump should have been evident during Christy's 2
previous annual examinations if they had been complete. By the time it was
diagnosed, the cancer had progressed beyond cure.

Breast
examinations by the physician, teaching of techniques for breast
self-examination, and recommendation of mammograms are now the standard of
care.

Mammography was developed in the 1950s and became a common
diagnostic tool in the 1960s. It is a key method for detecting breast cancer
early, when it is easier to treat. In 2005, about 68% of all US women
between 40 and 64 years of age had had mammography in the past 2 years, according
to insurance studies. All US states except Utah require private health
insurance plans and Medicaid to pay for breast cancer screening.

Standards for the timing of mammography vary by organization
and by patient history. The US Preventive Services Task Force currently
recommends that low-risk women older than 50 years receive mammography once
every 2 years. ACOG currently
recommends annual mammograms for all women 40 and older.

These are but a few examples of medical mistakes that have
led to patient injuries or death -- and have led further to changes in the way
physicians in the United States practice medicine. Recognizing that all of
these mistakes could have been prevented, the federal government and various
medical academies have developed guidelines for prevention and treatment of
many diseases.

 

馬英九的心與胸；中國馬英九，台灣薄熙來

[寫得真好 !  句句適切 !  小黨棍被選上總統，處處醜態。問題是，給這種人掌控台灣人的將來啊? 豈是用荒唐、神經、等用字可以描寫其後果的嚴重性!!!  台灣人，能夠想像世世代代失去自由民主的滋味嗎??]

 

馬英九的心與胸

馬英九被批無能，「心胸」狹窄，欠識人之明，無用人之量，致空言改革卻一事無成；諷剌的是，台灣選民心胸足以包容外來權貴，卻也無識人之明，致有咎由自取之嘆。

把「心胸」拆開，再作別解，馬英九的根本問題是「心」不在台灣。他不像本土政權，以台灣做為一個國家進行建設，照顧人民，凝聚國人的光榮感。

他心在中國， 志在被「統一」，因此，他要遏制台灣獨立自主意識，也不想做合乎公義的改革，只希望藉金錢麻痺民心，但台灣人民生活卻每況愈下。

他「胸」中才學，只知依附中國，別無繁榮台灣之策。有哈佛博士光環，說他「胸」中無物，那可能太誇張，但聽其言觀其行，他的「才學」不是來自台大，也非得自哈佛，而是來自國民黨培養的海工會黨棍文化。

國民黨海工會小黨棍，所學不外乎打小報告，瞞上欺下；搞遊戲「辦活動」；操練油嘴滑舌，言不及義；搞鬥爭，對付左派老共無能，對付「台獨」卻賣力；搞幫派文化，在小圈圈裡「有福同享」。

「轉大人」後，也未長進；以國家元首出訪，竟不知穩重與尊嚴，玩小黨棍遊戲；對民不聊生的苦難，只知嘻皮笑臉滑舌應付；不顧證據與正當法律程序，要對陳水扁趕盡殺絕；幫派文化豈容異類分沾？

馬英九滿口仁義道德，四書五經，但那是他要騙人民接受的封建帝王思想；他服膺的是馬基維利的唯權力論：為達目的不擇手段。

只要有利於他取得和保障權位，道德或公義可以置之不顧，一切承諾、背信、欺騙、謊言、脅迫、施惠，都可相機運用：他要當台灣民主化之後的袁世凱。

（作者王景弘，資深新聞工作者）

 

台灣智庫民調 馬不滿意度62.5％創新高

〔記者李欣芳／台北報導〕馬英九總統連任勝選至今已逾三個月，台灣智庫昨發布民調指出，高達六十二．五％的民眾不滿意馬英九的施政表現，只有二十六％的比率感到滿意。與台灣智庫上個月發布馬英九的不滿意度四十九．七％相較，馬的不滿意度一個月內暴增十二．八％。

嗆馬遊行 58.9％民眾支持

民進黨與台聯分別發動五一九、五二○大遊行嗆馬政府，這份民調也顯示，五十八．九％的民眾支持「人民應該走上街頭喊出自己的心聲」，三十二．二％民眾反對上街頭抗議。

台灣智庫委託趨勢民意調查公司，在四月二十三日、二十四日兩天針對二十歲以上民眾進行電話民調，並於昨天舉行「二○一二年民情調查」記者會發布。記者會由台灣智庫民調小組召集人徐永明主持。

對於馬英九將在五二○就職典禮發表演說，六十二．五％的民眾表明不支持馬英九在就職演說中宣布一國兩區，十六．八％的民眾表示支持。

油電雙漲 59.4％認馬不誠實

油電「選前凍漲、選後調漲」，五十九．四％的民眾認為馬英九不是一個誠實的總統，二十四．二％民眾持相反看法。

對馬政府近來「一國兩區」、油電雙漲的爭議，六十二％的民眾表示馬英九總統應該到立法院做國情報告，以接受立法院的監督，二十四．七％的比率則持相反看法。

對於發生上述爭議，四十四．一％的民眾認為「台灣選錯了總統」，高於認為沒選錯的四十三．五％。

至於行政院長陳冲的施政滿意度，五十一％的民眾感到不滿意，僅二十八．七％表示滿意。

與會的台聯立委林世嘉說，希望馬英九懸崖勒馬，未來帶領台灣走向正確方向。民進黨立委林佳龍表示，馬英九應該公開向人民道歉，祈求人民再給他一次機會。

關懷生命協會動保會執行長何宗勳強調，人民已經無法相信與依賴馬英九，未來台灣民眾須自力救濟。

 

〈鏗鏘集〉中國馬英九，台灣薄熙來

薄熙來在中國重慶以「唱紅打黑」聲勢高漲時，台灣的某些媒體用「中國的馬英九」形容他，以薄與馬相互拉抬吹捧。換句話說，台灣的薄熙來，馬英九是也。

從薄的親信王立軍向美領事館尋求政治庇護不成，一路暴露薄熙來令人咋舌的政治鬥爭之術，交雜著路線與權力競奪的中國共產黨政治真相；駭人聽聞的人權迫害、貪污、謀殺、淫亂……神鬼之間，一夕翻轉。

馬英九應該暗自慶幸：中國國民黨雖然被中國共產黨革了命，但在占據地台灣仍然一把罩。施政滿意度低落，仍然連任成功。生活在台灣的人們被戒嚴長期化的威脅、分而沾光的利誘、欺騙壓制成黨國順民的一大堆。民主化提供了選舉形式，正好被用來合法化中華黨國體制。

被說成是什麼並不等於是什麼？薄熙來今昔是同一個人，但他以政治權力配合撒錢神話他時，不就像馬英九的某種樣子？什麼好樣的都是他！但聽聽一些原來附和他的某些人說他多麼冷血殘酷虛假！還在第一任期內，馬腳半露就已經這樣，誇言尋求歷史定位的他，會怎麼樣？

看看馬英九的嘴裡說出「公平正義」的樣子，讓人想笑。不，是生氣！最最「不公平不正義」的不就是挾黨產不放的中國國民黨嗎？說要處理黨產，但做了快四年總統又是黨主席的他，說一套做一套。滿口仁義道德、典型的中國式一手讀經一手黑白摸的鬼樣子！

五二○在即，民調顯示現在總統大選，馬輸蔡英文，但是又何奈！馬敗象雖露，但藉著民主化選舉賦予他權力位置，他擺明了要怎樣就怎樣。躲在臉書裡，有權無責的他，操死閣揆（什麼最高行政首長!?），又玩死國會（是多數黨但多數是舉手部隊）。眼看著台灣被玩弄於股掌之間。

看看薄熙來，想想馬英九，政治這面鏡子正照著台灣的虛實光影。（作者李敏勇，詩人)

 

 

FDA says nanotech may need extra safety tests

WASHINGTON (Reuters) - U.S. health regulators said consumer products that use nanotechnology may have unknown effects on the human body, and advised food and cosmetic companies to further study the safety of these tiny particles.

The U.S. Food and Drug Administration issued two draft guidelines on Friday calling for more studies, putting, for now, much of the onus for safety on companies.

The FDA also rejected a consumer group's petition from 2006 that urged a separate category of regulation for nanotechnology due to its "unique human health and environmental risks."

Nanotechnology involves designing and manufacturing materials on the scale of one-billionth of a meter - so small it cannot be seen with a regular light microscope.

It is used in hundreds of products in areas ranging from stain-resistant clothing and cosmetics to food additives, but the health effects of nanoparticles are still poorly understood.

Nanoparticles may be able to penetrate the skin, or move between organs, with unknown health effects.

"Understanding nanotechnology remains a top FDA priority," FDA Commissioner Margaret Hamburg said in a statement. "FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices."

The FDA advised companies that use nanotech in food additives or food packaging to consult with the agency and show that the changes are safe before selling their products.

"The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant," the draft guide says.

Makers of most U.S. food additives and ingredients can tell the FDA that their ingredients are "generally recognized as safe" in order to legally sell them.

The FDA said nanotechnology does not automatically fall into this category, meaning companies would have to prove additional safety data before approval.

Erik Olson, director of food programs at Pew Health Group, a consumer advocacy group, said companies can often simply inform the FDA that certain food additives are safe. But the new guidelines for the first time show the FDA thinks nanomaterials deserve greater scrutiny.

"The FDA is essentially saying (to companies), we don't think you can just make your own decision a nanomaterial is safe without telling us," Olson said. "That's a fairly new development."

The International Center for Technology Assessment, which filed the 2006 petition, sued the FDA late last year for being slow to reply.

Jaydee Hanson, policy director at the center, said legal action may have prompted FDA to issue guidance for nanotech in food and cosmetics after a delay of six years.

"It's good that they're making recommendations in this area, but they haven't gone far enough," he said.

The European Union requires companies to prove a nanotech product is safe before it can be sold to consumers, Hanson said, while the FDA has only issued voluntary guidelines for companies.

For cosmetics, the FDA said companies should also do additional testing of products that, for example, use nanotechnology to create smoother-feeling moisturizers or lipstick.

The FDA does not require cosmetic companies to submit safety data before selling their products, and the guidance is unlikely to have a big impact on large cosmetic firms like Avon Products Inc, which already comply with European rules.

Avon said it adds nanomaterials like titanium dioxide or zinc oxide to cosmetic products to boost protection against the sun's ultraviolet rays and let sunscreens rub in without leaving white marks. It said the products were proven safe in the EU.

(Reporting by Anna Yukhananov in Washington, additional reporting by Phil Wahba in New York; Editing by Tim Dobbyn)

前總統李登輝 呼籲

人民再起 民主再改革

◎ 李登輝

近來，全國民眾心情應該很鬱悶，因為馬政府除了提出「一國兩區」這種形同放棄主權的主張外，更罔顧民意與人民健康，執意開放進口含瘦肉精牛肉；同時，政府帶頭漲價，油價漲、電價漲、連健保費也要漲，放任民生物價狂飆，這個政府完全不管人民的死活。

馬總統選前表示，選他台灣會更好，選後不但沒變好，還說自己已經沒連任的壓力，要大家面對痛苦多忍耐。人民雖不同意這種說法，卻無法有效制衡，讓我們看到台灣民主制度的缺失，應該是「民主再改革」的時候了！我所提的改革，是一種生活保障的改革，是生存保障的改革，是人民權利保障的改革。

台灣的歷史發展歷經不少政權統治，我曾說過這是「台灣人的悲哀」，但隨著民主運動的發展，社會力的支持，讓我能夠在總統任內推動改革，以寧靜革命的方式，將權力還給人民，讓台灣人民真正成為國家的主人。但仍有些改革尚未完成，像是司法改革、教育改革以及心靈改革等必須繼續努力，以建立台灣人的自主意識。改革是要人民過更好的生活，不是要人民忍耐痛苦過生活。

過去，台灣人無懼生命財產的威脅，走上街頭爭取選舉權、爭取言論自由。現在，總統已經直選，政權已經二次輪替，社會卻失去改革的動力，政治成為權位與利益的追求，人民的權利無法得到重視。台灣要再進步，唯有靠人民自覺，靠社會力推動，而不再是只寄望政黨，對任何違反民意的政黨都應該淘汰。

台灣在政治、經濟、社會各方面，無論是憲政體制、司法正義、社會公平、媒體公正、環境保護、土地正義、健康人權、弱勢照顧等等，都存在不少問題；譬如憲法增修條文前言中，以統一為前提的規定，已經不符合大多數人民的意志；國會選舉得票數多數黨與少數黨差距不大，席次卻非常懸殊，票票不等值；憲法修改的唯一發動權掌握在立法院手上；人民要發動公投卻被套上層層限制，無法表達直接民意；社會的貧富差距愈來愈大，公平正義無法彰顯。面對這些不公不義，我們需要進行全面性的再改革。

過去人民將自己的權利保障寄託在政黨，人民為了過生活，無暇關心公共利益，以致無法凝聚改革的力量。今天，我要提醒所有的台灣人，權利是靠自己爭取來的，權利不會從天而降，只有人民自覺，發動公民社會的力量，推動民主制度的再改革，才能真正落實人民當家做主的目標。

台灣一向有堅強的生命力，是因為台灣人有打拚的精神，現在遇到一些阻礙，有些氣餒。但是，台灣人並沒有失去對公義精神的追求，像是最近大家對政府強拆台北士林王家的關心，之前對苗栗土地徵收事件大埔阿嬤的支持，不滿恐龍法官判決的白玫瑰運動，都展現出台灣人追求公義的精神。

我要跟全國民眾共同勉勵，千萬不要失志，要保持對國家的熱情，保持對同胞、土地的疼心，對自己要有信心，用行動實踐改革的力量。讓我們從關心身邊不公平的現象開始，無論是憲政體制、司法正義、社會公平、媒體公正、環境保護、土地正義、健康人權、弱勢的照顧等等。政府不改，政黨不關心，人民就應該展現力量，用當年爭取民主改革的精神，進行民主的再改革，為台灣世世代代的幸福繼續拚下去！

（作者為前總統）

 

李登輝批馬：自以為在當皇帝

李登輝前總統昨天持續走訪高屏地區，他前往恆春生態農場綿鐘攬月樓，為自己親題的「吾土吾民」石碑揭碑，並拿紅包分贈給前來舞龍舞獅的小朋友；李登輝稍後發表演說，砲轟馬英九總統，指有人選上總統，以為自己在當皇帝。 （記者李欣芳攝）

〔記者李欣芳／隨行報導〕李登輝前總統昨天持續走訪高屏地區，他批判馬英九總統指出，有人選上總統，以為自己在當皇帝，經濟做不好、司法改革做不好、人民失業嚴重，卻帶頭大漲油電價，這個政府現在什麼都要漲，要老百姓如何過活？

號召民眾推動「民主再改革」

昨天是李登輝下鄉的第二天，看到質樸的台灣人民很努力，卻遭到不少困難後，他號召民眾推動「民主再改革」。

李前總統在恆春生態農場向地方人士發表演說時強調，過去台灣人不惜生命財產的威脅，走上街頭爭取民主，但民主只做一半，只是選舉，失去改革的動力，台灣民主需要再改革。

李登輝指出，過去中國五千年歷史，以皇帝為中心，皇帝做不好，就有人起來反抗、推翻，所以歷經許多朝代，但那種社會不適合台灣，現在不能再有皇帝心態。

什麼都漲 要老百姓如何過活

他話鋒一轉，抨擊現任總統馬英九，有人選上了總統就以為自己在當皇帝！現在這個政府，什麼都要漲，要老百姓如何過活？但是，大家不要因此「失志」，要站出來，台灣的民主需要再改革，最重要的是民主的道路，地方要有力量。

李登輝指出，中央太過集權，不要管那麼多，應由地方來管，地方應團結起來，屏東縣、高雄市可以合起來，一起努力做更多事，例如中央說要漲學費，地方政府可說：「對不起，我們不要漲！」大家團結起來，力量會更大。

中央太集權 地方團結硬起來

繼昨天上午批馬總統以為自己是皇帝後，李登輝昨天下午也在高雄暗批陳水扁前總統，他說，自二○○○年以後，當選總統的人就以為自己在當皇帝，他不要特別說誰，這是教育的問題，以為自己是皇帝，跟自己有關係的事情是太太在管。

李登輝昨天上午在恆春生態農場爬了三十六階的階梯，為農場的綿鐘攬月樓進行揭碑儀式，碑上有李登輝所提「吾土吾民」四個字，他並登上涼亭階梯，親自撞鐘三十三響，展現好體力。隨後，李登輝回到農場餐廳，對地方人士發表演說。

昨天下午，李登輝由屏東縣長曹啟鴻陪同參觀屏東二峰圳水利工程，後來轉赴高雄市，與市長陳菊等人茶敘。李登輝先後向曹啟鴻、陳菊，建議高雄市與屏東縣政府合作，例如追討台糖公司所占土地及學費不漲價等教育問題等的合作。

籲高屏合作 討回台糖占用地

他說，面對中央的獨裁、集權，兩縣市聯合起來，那會不得了！他並向曹啟鴻表示，要硬起來，聯合南部其他縣市，把台糖占據的土地給要回來，對於這項提議，曹啟鴻特別感謝李登輝。

關於李的建議，陳菊則說，只要取得屏東縣議會的同意，就可進行高屏合作。

 

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李登輝：馬應到立院國情報告 李登輝前總統（圖左）昨與高雄市長陳菊（圖右）茶敘，並接受媒體訪問時表示，他認為馬英九總統應該到立院國情報告。（記者李欣芳攝） 〔記者李欣芳／高雄報導〕在野黨要求馬英九總統到立法院國情報告掀爭論，李登輝前總統昨表示，馬總統到立院國情報告是應該的，「要是我，會很高興，趕快去報告！」 被問到總統到立法院做國情報告的問題時，李登輝說，這是馬英九的事，不過，美國總統也得到國會報告，民主社會，總統是由人民選出，國會議員也是民選的，連這種事都不了解，還要做領導者？李登輝是在高雄旗山接受媒體提問時做以上表示。 盼台灣不要回復威權獨裁 李登輝說，現在沒有國民大會，中央民意機關只有立法院，他希望台灣不要回復威權獨裁，若是這樣，總統沒人管。李登輝也說，立委選舉制度等問題也應檢討。 媒體詢及民進黨如何守穩台灣主體性與中國交流？李登輝說，民進黨有時候給人的感覺是怕怕的，不參與，例如，明明就沒有「 九二共識」，民進黨要大聲說出來。 李登輝並指出，台商在中國面臨的困難很多，民進黨沒研究相關問題，卻怕得要死，台灣是個國家，雖然還沒邁向真正的正常國家，但向中國人說清楚就好，應以勇敢的態度面對問題。 李登輝並透露，有關他因國安密帳案遭起訴一事，到現在快要一年了，都沒開庭；他意有所指地說，可能那時候（指總統大選時）不知誰會選上，現在選上了，安心了，可能認為不處理也沒關係。 李登輝說，「我在等，因為這一生被這個問題所困住」。他還請了三個律師，律師要求閱卷，法院說相關證據都是機密，這就不公平了，律師都沒看到起訴的相關資料。

 

李先生出手 令後生汗顏 記者鄒景雯／特稿 李登輝每次一出手，就會讓人感嘆台灣政治人才的斷層何以這麼嚴重？陳水扁與馬英九是一九四九年國民黨敗逃台灣後成長的一代，受到完整的國民黨黨國教育，然一個被人逮到把柄關進牢裡，一個是假道學正在台上胡搞。下一個世代，又沒一個能超越現在大家所嫌棄的。孕育不出像樣的領袖，才會發生九十歲老人家還要如此操勞的反常現象。 李先生昨天講了幾句令後生汗顏的話，一句是：有人選上總統，以為是在當皇帝；第二句是每樣漲，老百姓要怎麼生活？第三句是：台灣民主的下一步，要落實地方自治。一一四選後迄今，檯面上的朝野菁英，哪個人講過這麼切中要害的話？為什麼講不出來？高度不夠，全是些政治矮仔？ 在野的不行，也就算了，在朝的虛矯濫權，人民就要倒楣。何以稱其虛矯？最近又有新事例update。馬英九在國民黨中常會宣稱要找省油省電的達人，來教大家省點錢；結果呢？立委公布馬政府居然編了四千三百多萬元來籌辦馬英九的就職大典，財政部國債鐘的最新數據每位國民承擔中央政府負債已突破廿二萬元，在政府債台高築的時候，這筆錢為什麼不想辦法節省？其實，達人不假外求，馬英九大可現身說法他是如何一年光存款就能增加三一○萬的？大家肯定能獲益良多，但千萬別說是「花公家省自己」才好。 最近的瘦肉精、油價、電價、甚至房價，只是「當皇帝」的一系列起身炮而已，預示了馬英九不再選舉後的決策模式。準備要全國繞一圈的李先生主張地方團結起來，減少中央的集權；老實講，在缺乏領袖、失去典範的年代，不僅地方要團結起來，所有的公民更要團結起來，一流的國民不必受三流政客的支配，由自己來當人民英雄，怎麼當？就從表示反對開始吧！

美國醫療官司新口實

www.medscape.com

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Authors and Disclosures

Author

Anthony Francis, MD, JD

President, Legal Medicine Research, Bel Aire, Kansas

Disclosure: Anthony Francis, MD, JD, has disclosed no relevant financial relationships

From Medscape Business of Medicine

Chilling New Ways Patients Are Suing Doctors

Anthony Francis, MD, JD

Posted: 03/29/2012

Introduction

Just when you think doctors have enough to worry about with malpractice lawsuits, plaintiff attorneys are becoming more aggressive with new traps. Malpractice tort law is a matter of "drawing lines" concerning a doctor's duty and the foreseeability of outcomes -- in other words, rules concerning liability are arbitrary. These new trends have the potential to redraw the lines and negate some of the benefits tort reform has brought to physicians.

Several novel approaches for bringing suit diverge from standard medical malpractice cases. Plaintiff attorneys have attempted to expand tort law to successfully sue physicians, such as "loss of chance," failure to medically monitor, and civil rights violations.

Loss of Chance: Getting a Scary New Spin

In October 2011, the Washington State Supreme Court recognized "loss of chance" as a new cause of action.

The expansion of loss of chance is an important new trend in tort law. The first case took place in Hawaii where the Ninth Circuit affirmed the new doctrine in federal law in 1972. As an active doctrine, it remained dormant for several decades but began to be increasingly recognized in the late 1990s. About half the states now accept it. The cases involve "what might have been" if medical treatment or a diagnosis had taken place earlier. It involves speculation and depends on expert testimony concerning statistics.

In states that recognize this tort, if there is less than a 50% chance of survival or medical improvement, plaintiffs usually have not been able to recover. However, in a new twist, in 2008 the Massachusetts Supreme Judicial Court , in Matsuyama v. Birnbaum, allowed the cause of action to go forward where the testimony clearly indicated a loss of chance < 50%, joining the Supreme Courts of Wyoming and Delaware in allowing damages below the 50% threshold.

In this case, a patient, Mr. Matsuyama, saw the defendant doctor, a board-certified internist and the plaintiff's primary care doctor, for a physical in July 1995. He complained of gastric distress, which was diagnosed as gastritis. However, it turned out that Mr. Matsuyama had gastric cancer. He died in October 2000, leaving behind a wife and child. The plaintiff's expert testified that the doctor committed medical malpractice by not ordering the appropriate tests.

After a 6-day trial, the jury found the doctor negligent and that his failure to order certain tests was a "substantial contributing factor" to Mr. Matsuyama's death. They awarded the estate $160,000 for pain and suffering but also awarded damages for "loss of chance." They calculated the damages at $875,000 for "full" wrongful death, even though Mr. Matsuyama was suffering from stage II adenocarcinoma at the time he saw his physician and had a 37.5% chance of survival at that time. The jury awarded the plaintiff "final" loss of chance damages of $328,125 ($875,000 multiplied by .375) for a total of $488,125.

The Massachusetts high court determined that even though the plaintiff had less than a 50% chance of survival, Massachusetts should join the "substantial and growing majority of the States that have considered the question" and find that the 50% all-or-nothing rule is unsatisfactory. This trend will also increase the level of defensive medicine and the ordering of more tests.

Regaining Popularity: Suing for Potential Future Problems

Suing for future potential problems has been around for about 20 years but is gaining in popularity now. It arose from various class action suits involving exposure to toxic substances. The gist of the action is that a plaintiff may develop pathology in the future because of toxic exposure.

Traditional tort law requires establishing damages by the time the case is tried. So this new tort seeks damages for conditions that have not been identified at the time of the trial but may emerge in the future. It seeks monetary damages to "monitor" the plaintiff in the future. This represents a new wrinkle in individual cases.

In a 1997 case, the United States Supreme Court rejected "medical monitoring" as a legitimate claim. This decision effectively decreased the number of medical monitoring cases filed at the state level. However, in 2006 in Massachusetts, Kathleen Donovan sued Philip Morris USA on behalf of former heavy smokers. They didn't seek monetary damages but wanted the court to grant a program of low-dose CT scanning to screen for future lung cancer. In 2009, the Supreme Judicial Court of Massachusetts reversed the antiscreening trend and handed down an opinion allowing claims for medical monitoring to go forward.

Normally, the case would have been dismissed because the plaintiffs could not prove current injury. This represents an expansion of tort law that could easily be used to define a new standard of care: failure to monitor.

'However, not all states are going in that direction. In a 2007 North Carolina case, Curl v. American Multimedia, the allegation of "future likelihood of disease" was rejected. The plaintiffs claimed that the defendants were liable for contamination of their wells.

On the basis of these claims, the plaintiffs sought damages for medical expenses, pain and suffering, the increased likelihood of future disease, and the cost of medical monitoring. The North Carolina court was reluctant to create a new cause of action.

Plaintiff attorneys have sued for medical monitoring costs involving all types of products and activities, including potential hazards from cigarettes, operation of landfills, radiation, PCBs, pharmaceuticals, electric and magnetic field radiation, radiofrequency energy emissions, asbestos, and implanted medical devices. These claims have generally been barred.

Regardless, the 2009 ruling in Massachusetts has set a new precedent. Several states, such as Ohio and West Virginia, have recently accepted failure to monitor as a tort. A pending case in New York State is expected to arrive at a similar conclusion.

Claiming Civil Rights Violations

Many states have enacted civil rights laws that complement federal civil rights and disability laws. In an attempt to avoid traditional medical malpractice requirements of expert testimony and pretrial affidavits, some plaintiffs have filed civil rights cases, obviating the need for expert testimony.

In a case from 2012 in St. Louis, Amanda Crider, who is deaf, filed a lawsuit against a hospital after she alleged that she had continued pain after receiving an epidural during childbirth. She had requested "natural childbirth," but as the labor progressed it became apparent to the medical staff that an epidural was advisable.

She claimed that there was a failure to advise her in sign language of the necessity of the epidural. She also claimed that there was no mention of the risks, and she alleged that she had unremitting back pain after the epidural.

Crider failed to provide an affidavit of probable medical negligence at the time her case was filed, as required by Missouri law. Instead, she claimed her civil rights were violated. This tactic circumvented the need for expert testimony.

However, the trial court dismissed the case. The appellate court affirmed the dismissal, stating that the thrust of the action was medical malpractice, not civil rights. She had not met the requirements of establishing a case of medical negligence.

Despite this, claiming a civil rights violation instead of medical malpractice is a growing trend. Many recent cases against doctors fall under the umbrella of civil rights, especially as it pertains to any disability defined by the state or federal law.

The expansion of civil rights will allow plaintiffs to file a case alleging a civil rights violation in conjunction with, or in lieu of, a malpractice case. Even though the plaintiff may lose in the end, there is the aggravation, stress, and cost for the physician to defend the suit. These actions fall under "failure to accommodate" for the disability.

Conclusion

Of the 3 new ways that patients are attempting to sue doctors, medical monitoring and loss of chance are the greatest threats to physicians. While the chance of success of such suits may not be high, the aggravation, time lost, and potential damage to a physician's reputation make these threats a legitimate cause for concern.

Medscape Business of Medicine © 2012 WebMD, LLC

還是KMT厲害!

[很令人納悶，這些以億元計數的花博、不合理的超巨額 國內建設、軍售、核電廠、、、，等無數億元的浪費，錢到底是哪去了?   難道蒸發了?  物理界也有質能不變定律。 錢也不會無故消失，或有人當冥紙燒掉。  總是有人在暗笑吧?  中共貪汙以十億、百億計，可是還會透露出來是哪些人霸走了。從wikileak可看出美國情報都查到中國貪汙者，KMT主政時期的這些國家財產就是不知道如何會消失、被汙走，還是KMT厲害啊 ! 真是厲害，只見當關後錢財增加； 高官卸職後，個個到中國開公司享樂，就是沒有人透露錢是如何來的。可能是一夥人都分得到紅，  嘴巴塞住了，各個暗笑?!； 或是知道內情的人，污點、弱點被抓住了，各個講不出話!? KMT 厲害啊，厲害!  損失的、苦的，就是一般百姓。 DPP也真差勁!  就是無法查出KMT主政時期，以億元單位計數的國家財產去向。 倒是在DPP主政後，幾十個人卻為了幾萬元被調查個半死、背上貪汙犯污名、發神經，最後判無罪，也沒有人再敢大聲說話。DPP還主張 "和平、理性" 呢，競選時期還拒絕大公司的捐助， 寧可小額捐款，寧可選輸。 好乖、真富於理念哦!  要為理念犧牲，做為民主先例呢。   不過，是否沒有看清馬桶這類校園間諜出身、無信無義者的性格本質了?   自己是否也缺乏亂世爭雄的氣概、魄力、與能力?  也難怪被人嘲笑是台巴子， KMT真是厲害!   DPP很 "理性" !!]   6支億元// 核二螺栓 網路1支2418元 核二廠更換六支螺栓，花了台電近億元，號稱「核能級」螺栓網路上也買得到，專家實際訪價，一支只要台幣兩2418元，奇異報價一支卻要250萬元。（記者湯佳玲攝） 〔記者湯佳玲、林毅璋／台北報導〕台電公司花費台幣近一億元更換核二廠六支毀損螺栓，但專家實際訪價後，台電聲稱的「核能級」螺栓其實網路上都買得到，一支只要台幣兩千四百一十八元，奇異報價一支卻要兩百二十五萬元。 台電：核能級特殊規格 包套價 原能會主委蔡春鴻日前在立法院專案報告時指出，核二廠一號機斷裂的反應爐支撐裙板錨定螺栓規格為ASTM（美國材料試驗協會）A-540 Gr. B23/B24 Class1，直徑三吋，長度廿六吋，重量廿三．六三公斤。台電隨後發佈新聞稿解釋，此為核能級特殊規格，國內、外供應商並無庫存，加上包套價格，所以要價約一億元。 台電核能發電處處長林德福則說，奇異的報價中，十五％是材料費（約一千三百五十萬台幣），剩下的八十五％都是技術服務。 經營大地工程與鑽探業務的王偉民指出ASTM A-540 Gr. B23/B24 Class1型號的螺栓，就是一般的高強度合金鋼，是建廠常用器材，主要用來固定機具。 坊間3萬元材料 奇異報價1350萬 王偉民出示「標準機械設計圖表便覽」一書指出，ASTM A-540 Gr. B23/B24 Class1是美式規格，對照日式規格為SNB23-1，「網路上都買得到」。例如，中國昆山市三川模具鋼材有限公司和中國蘇州赫川金屬製品有限公司，都有販售同款螺栓，標價為每公斤廿二元人民幣，乘以廿三．六三公斤，再換算成台幣約為兩千四百一十八元；最貴的是昆山四通模具鋼材有限公司，一公斤廿八元，換算下來一支三千零七十六元。若再加上螺紋滾製壓軋成型與螺帽費用約一千五百元，坊間三萬元以內即可買到的材料，台電卻花了一千三百五十萬元。 台電：安全不能等 只能找奇異 林德福證實ASTM A-540 Gr. B23/B24 Class1與日規的SNB23-1是為同一材質，只是美國、日本各有認證編號。他強調，更換核電螺栓要跟時間競賽，安全不能等；中國廠家的東西不敢用，只能找有核能經驗，在工程分析、品保等方面，又快又符合程序的奇異公司。 核電專家林宗堯指出，核能級產品必須經過一關又一關的品質控制與品質確認、儀器設備校正等，以確認雜質、應力和細縫符合標準，雖然材料都一樣，但在人員、工時與工序上更加繁瑣，價格會多出兩到三倍，「但是總價一億元也太離譜了！」 立委指6支最多60萬 合約離譜 立委羅淑蕾表示：「一般核電廠該級螺栓的材料含安裝費，六支只要大約六十萬元，台電卻接受奇異一千三百五十萬元的材料報價，不知道當初合約是怎麼簽的？究竟是台電笨？還是有弊端？這種價格的材料費太離譜了，讓人無法接受。」立委田秋堇則說，既然一支螺栓沒多少錢，貴的是know-how，台電何不全部更換。 原能會副主委周源卿表示，對螺栓價格外行，不會過問台電花多少錢，只管安全。

用high intensity focused ultrasound 治療 prostate cancer

Experimental Prostate Cancer Treatment
Shows Promise

By Alexandra Sifferlin

Read more: http://healthland.time.com/2012/04/17/experimental-prostate-cancer-treatment-shows-promise/#ixzz1sQrZeJrj

An experimental treatment for prostate cancer tumors
using high-intensity focused ultrasound (HIFU) shows promise as an effective
treatment with fewer side effects than existing therapies.

The idea behind the new procedure is
similar to lumpectomy in breast cancer patients, in which doctors remove only
the tumors instead of the entire breast. Using HIFU, doctors can focus on
treating only the cancer cells on the prostate while causing minimal damage to
the surrounding tissue. Unlike more common and invasive treatments such as
radiotherapy and surgical removal of the prostate gland, HIFU may be able to avoid side effects like urine leakage
and impotence.

The new study, designed as a proof-of-concept study, involved
just 41 men. Doctors used MRI and mapping biopsies to locate the cancerous
tissues. They then focused
high-energy sound waves on the affected area, causing the cancer cells to heat
up to around 80°C, which kills the cells. None of the patients reported
urinary incontinence a year after treatment, and only 1 in 10 suffered from
poor erections. Overall, about 95% of
the men were cancer-free after a full year following the trial.

“The signal from this study is quite strong,” study
author Hashim Ahmed, a urologist at the University College London, told Bloomberg. “When you look at the current standard of
care, there’s a 1-in-3, or 1-in-2 chance of having the perfect outcome. In this
study, after 12 months, it’s a 9-in-10 chance.”

The men in the study were aged 45 to 80 with medium- to
high-risk cancer, and would likely have undergone surgery or radiotherapy down
the line. Men who had already received chemotherapy, hormone treatment or
radiation therapy were excluded from the study. The procedure was carried out
under general anesthesia and most of the patients had hospital stays of less
than 24 hours after the treatment.

“Focal therapy of individual
prostate-cancer lesions, regardless of whether they are multifocal or unifocal,
leads to a low rate of genitourinary side-effects and an encouraging rate of
early freedom from clinically significant prostate cancer,” the authors concluded in the study.

Prostate cancer is the most common cancer among men. The
National Cancer Institute estimates 241,740 new cases of prostate cancer this
year in the U.S. and 28,170 deaths.

Ahmed told Bloomberg that HIFU may also be cheaper than
other standard treatments, noting that the cost of the MRI and mapping was
an estimated $2,400, plus about $1,600 for HIFU; in comparison, removing the
prostate costs about $7,100. Fewer side effects would also lower other health
care costs, he said.

The researchers are now recruiting more patients and
seeking funding for larger studies. While the initial results were promising,
they need to be replicated; HIFU also needs to be studied long-term and
compared with other therapies. If the technology holds up, it could also work
for other cell-based cancers like breast, thyroid, pancreas and liver, Ahmed
said.

The study was published Tuesday in the
journal The Lancet Oncology

Read more: http://healthland.time.com/2012/04/17/experimental-prostate-cancer-treatment-shows-promise/#ixzz1sQrNpSYi

 

用 florbetapir (Amyvid) 或 florbetaben 可以(用PET)偵測Alzheimer&#39;s 腦內 amyloid；怎麼用?

U.S. gives nod to Eli Lilly's brain plaque test

WASHINGTON (Reuters) - U.S. regulators gave the nod to an imaging test from Eli Lilly and Co. that can for the first time help doctorsdetect brain plaque tied to Alzheimer's disease, the company said.

The U.S. Food and Drug Administrationapproved the radioactive dye, called Amyvid, to help doctors rule out whether patients have Alzheimer's, the most common form of dementia, Lilly announced late on Friday.

The dye binds to clumps of a toxic protein called beta amyloid that accumulates in the brains of patients with Alzheimer's. Doctors can then see the plaque light up on a positron emission tomography, or PET, scan.

Patients with Alzheimer's always have some brain plaque, so its absence in the test would tell doctors to look for other causes of mental decline, such as depression or medications, Lilly has said.

But Lilly, which plans to sell the drug through its unit Avid Radiopharmaceuticals Inc, said the test should not be used to diagnose Alzheimer's, since brain plaque can also be tied to other neurologic conditions and may occur naturally in older people with normal mental states.

An FDA advisory panel recommended against approving the dye last year, saying doctors might have trouble interpreting scans of the plaque, and the FDA rejected Amyvid last March.

Since then, Eli Lilly said it has worked to identify better ways of training doctors to use the test.

Dr. Daniel Skovronsky, CEO of Avid, said one in five patients who are diagnosed with Alzheimer's turn out not to have the disease after an autopsy.

"The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients," he said in the company's statement from Friday.

There is currently no cure for Alzheimer's, a mind-robbing disease that affects more than 35 million people worldwide and gets worse with age.

But an early hint that something is wrong might improve the success of drugs meant to prevent or delay disease progression, researchers believe.

Avid has been in the lead in the race for imaging agents for Alzheimer's, which are estimated to have a potential global market anywhere from $1 billion to $5 billion.

General Electric Co and Bayer AG are developing rival products.

Lilly, as well as Pfizer Inc, are the farthest along in developing experimental medicines to treat Alzheimer's. Lilly expects to release final data for its contender, solanezumab, as soon as this summer.

(Reporting by Anna Yukhananov; editing by Todd Eastham)

Another Amyloid Tracer Shows Promise in Alzheimer's

Pauline Anderson

April 17, 2012 — On the heels of the US Food and Drug Administration (FDA) approval of the amyloid tracer agent florbetapir (Amyvid, Eli Lilly), another biomarker is showing promise in detecting beta-amyloid deposition in the brains of living patients.

A study using florbetabenshows that imaging data obtained before death by using this new tracer with positron emission tomography (PET) correlate well with autopsy findings.

"We've been really desperate to have a biomarker —whether it be spinal fluid, blood, magnetic resonance imaging, PET — something that would increase our accuracy, and this florbetaben study helps in that arena," said lead researcher, Marwan Sabbagh, MD, director of Banner Sun Health Research Institute in Sun City, Arizona.

Full results of the study will be released at the upcoming annual meeting of the American Academy of Neurology. The study was funded by Bayer Healthcare. Another company, Piramal Healthcare Ltd, has recently signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG through a newly created subsidiary called Piramal Imaging SA, a news release from Piramal notes.

"Game Changer"

Clinicians have struggled with diagnosing Alzheimer's disease with confidence while a patient is still alive, Dr. Sabbagh noted. "Products like these give us ammunition in our arsenal to make a diagnosis with more confidence," he said. "The concept of amyloid imaging is a game changer; it will allow physicians to use in vivo diagnostic tools in ways that we have never, ever, done before and I think it really is exciting."

As with other companies developing an amyloid biomarker, the makers of florbetaben "started imaging people near death, gathering specimens, and comparing side by side, brain by brain, slice by slice — to see if it was positive on a scan was it positive on an autopsy and vice versa: if it was negative on a scan, was it negative on an autopsy," said Dr. Sabbagh.

The results of this new research demonstrate that florbetaben was "highly accurate," he said.

The phase 3 study included 204 end-of-life patients from 17 centers across 4 continents who underwent magnetic resonance imaging (MRI) and florbetaben PET before death. Ten healthy individuals were also included to support specificity.

The results of these scans were then compared with the amount of plaque found in 31 participants who reached autopsy. The analysis included 186 brain regions from donors and 60 regions from the healthy volunteers.

The autopsy was photo-documented in detail to allow for alignment with the MRI/PET images. Beta-amyloid in the tissue was detected by silver-staining and immunohistochemistry. The presence or absence of beta-amyloid was determined by a consensus panel of 3 neuropathologists blinded to all clinical and imaging data.

Two Methods

The study analyzed data in 2 ways, said Dr. Sabbagh. One, the visual assessment method, was a side-by-side comparison of whole-brain imaging features (amyloid positive/negative) to autopsy features (amyloid positive/negative). In that analysis, they found 100% sensitivity and 92% specificity, he said.

The study team went a step further and performed a side-by-side comparison (image/autopsy) in 6 different regions in the brain. This type of comparison was used to verify that florbetaben actually detects in the area of disease — that is, the gray matter — explained Cornelia Reininger, MD, PhD, associate professor of surgery, senior director of clinical research, Bayer Pharma AG, Global Clinical Development.

"It was designed to directly compare (region by region) in 6 prespecified regions of the brain — whether florbetaben gray matter uptake in the scan actually correlated with the presence/absence of beta-amyloid in the respective histopathology," she told Medscape Medical News. "The methodology is unique, provides exact verification of gray matter (beta-amyloid specific) vs white matter uptake (nonspecific) of the tracer compared to histology."

That second analysis found that florbetaben depicted amyloid on the scans with 77% sensitivity and 94% specificity.

This double approach is "a very exact" method of verifying both the efficacy of the tracer to bind amyloid and the visual assessment that doctors will in the future be using to read the scans, said Dr. Reininger.

Although the agent is not yet approved, Dr. Sabbagh said he and his colleagues "will be anticipating that the company will move forward with filing and registration with the FDA."

Although cost and availability may be issues to start with, these should eventually be ironed out, said Dr. Sabbagh. "At the beginning, you will see some challenges in taking it up, but over time, I think these will become commonly used technologies."

As with similar agents, training of physicians to read the scans accurately will be another issue. It's important to be able to look at a scan and say whether it's positive or negative, said Dr. Sabbagh. Using "binary reading" (positive or negative) rather than a "numerical scale" should in some ways simplify the training process, he said.

Dr. Sabbagh said he's not concerned that this agent is being developed in the absence of a truly effective Alzheimer's disease treatment. "Diagnostics and therapeutics are created in parallel, never together," he said.

He also noted that phase 3 results of 2 large immunotherapy studies using investigational agents bapineuzumab and solanezumab will be reported later this year.

Comparable Agents

Asked to comment on this research, Liana Apostolova, MD, Alzheimer's Disease Research Center, University of California, Los Angeles, said florbetaben is a chemical to similar to the already approved florbetapir.

"They are pretty comparable" in that they both bind to amyloid in the brain, she told Medscape Medical News. She stressed, however, that few if any head-to-head studies have been done.

Asked for his opinion, David Knopman, MD, Department of Neurology, Mayo Clinic, Rochester, Minnesota, said he found the accuracy of florbetaben to detect amyloid reported in this study to be "indeed encouraging."

The study will be released as part of the Emerging Science Program (formerly known as Late-Breaking Science) at the American Academy of Neurology 64th Annual Meeting in New Orleans, April 21 to April 28, 2012.

Medscape Medical News © 2012 WebMD, LLC

 

Florbetapir Approved: Now How Do We Use It?

Pauline Anderson

April 19, 2012 — Florbetapir (Amyvid, Eli Lilly/Avid Radiopharmaceuticals), a new agent to detect beta-amyloid plaques in living patients with possible Alzheimer's disease (AD), has just been approved by the US Food and Drug Administration (FDA). The question now is how this imaging option will be used in practice.

Although they are for the most part enthusiastically awaiting access to this new agent, expected to be available by June, many neurologists are also striking a cautionary note. Cost, availability, the need for expert interpretation of scans using the florbetapir tracer, and what it really means for a diagnosis of AD are a few of the concerns being raised.

Medscape Medical News polled experts in the field of AD to see how they view the approval and how they see this diagnostic tool may fit into their clinical practice.

Diagnostic Dilemmas

Florbetapir is a diagnostic agent tagged with a radioisotope, fluorine-18. Used with positron emission tomography (PET), it binds to amyloid plaques in the brain. Approved by the FDA on April 9, florbetapir is 1 of 3 imaging agents in various stages of development; others are florbetaben (Bayer/Piramal Imaging SA) and flutemetamol (GE Healthcare). All are reported to detect amyloid deposition in the living brain.

Left: High Amyvid uptake in cortical grey matter (loss of grey-white matter contrast). Right: Low Amyvid uptake in cortical grey matter (good grey-white matter contrast). Eli Lilly and Company and Avid Radiopharmaceuticals

Although the presence of amyloid on the scan doesn't necessarily mean the patient has AD, a scan showing little amyloid deposition, "is inconsistent with a neuropathological diagnosis," of AD, a press release from the company at the time of approval notes. The statement added that the safety and effectiveness of florbetapir have not been established for predicting development of dementia or other neurologic conditions, or for monitoring responses to therapies.

Still, the use of florbetapir may clear up some diagnostic dilemmas, said Sandra Black, MD, professor, Department of Medicine, Division of Neurology, University of Toronto, Ontario, Canada. "It might help in situations where you're not quite sure what's going on — when you don't know whether this is aphasia due to AD or a frontal temporal dementia-type thing."

Pedro Rosa-Neto, MD, assistant professor, neurology, neurosurgery and psychiatry, McGill University, Montreal, Quebec, Canada, felt that the new tracer could be informative in the investigation of patients with early onset or atypical presentations of dementia to rule out AD, and in cases of rapidly progressive dementia.

"Rapidly progressive Alzheimer's disease is a highly neglected condition, frequently misdiagnosed as Creutzfeldt-Jakob disease," Dr. Rosa-Neto noted. For these selected cases, he sees PET using florbetapir adding to the information gained from the clinical history, various magnetic resonance imaging (MRI) modalities, including fluid-attenuated inversion recovery and diffusion-weighted imaging, cerebrospinal fluid sampling, and neuropsychological and genetic evaluations.

Although the tracer could be of assistance in patients with dementia in whom it's unclear whether amyloid is a cause of cognitive deterioration, it would not be as useful an addition in cases where all clinical, cognitive, and imaging findings strongly point to the presence of AD, said Liana Apostolova, MD, Alzheimer's Disease Research Center, University of California, Los Angeles.

"While the test could be useful to confirm that presumption, dementia specialists can already diagnose AD under these circumstances with high sensitivity," she said. "This is when I might say, 'I'm pretty certain what's going on at this point; I don't need to subject the patient to this expensive diagnostic procedure."

Role in Mild Cognitive Impairment?

Some clinicians agreed that there is a place for the new biomarker in patients with mild cognitive impairment (MCI). Ronald Petersen, MD, PhD, director, Alzheimer's Disease Research Center, Mayo Clinic, Rochester, Minnesota, credited with developing the concept of MCI, said the tracer "will be helpful" to see whether amyloid can explain memory problems experienced by these patients. "It will not make the diagnosis, but it will help the clinician sort out the cause of the symptoms."

Dr. Petersen pointed out that many patients with MCI — perhaps up to 40% — don't have AD as the underlying cause of their cognitive problems.

For Steven T. DeKosky, MD, vice president and dean, University of Virginia School of Medicine, Charlottesville, the new biomarker "seems like a reasonably accurate detector" of whether MCI is AD in development or whether it relates to some other cause.

Other physicians said they wanted to avoid using the new tracer in cases of MCI.

"Although I think a positive amyloid imaging study would increase the likelihood that the person will decline, that is not known for certain," said David Knopman, MD, Department of Neurology, also at Mayo Clinic Rochester, Minnesota. "So, I would definitely not do an amyloid scan routinely."

Doctors stressed that a positive scan does not necessarily mean an asymptomatic patient will develop AD. "Many cognitively normal elderly will show amyloid deposition in their brains as the disease is believed to have an asymptomatic stage that lasts up to 20 years," pointed out Dr. Apostolova.

"I don't think we know enough about the prognostic factors of a positive amyloid scan," said Adam S. Fleisher MD, director of brain imaging, Banner Alzheimer Institute, Phoenix, Arizona, during a Web-based debate on the role of neuroimaging in the diagnosis of AD earlier this year.

On the other hand, a negative scan may not mean a patient is out of the woods because there could be another explanation for their cognitive problems, such as vascular dementia.

"We will have to be very careful using amyloid imaging and making sure patients understand that a negative scan is not necessarily a cause to celebrate," said James B. Brewer, MD, PhD, associate professor, radiology and neurosciences, Human Memory Laboratory, University of California at San Diego, who also participated in the Webinar.

Possible other causes of cognitive decline could include stroke, thyroid problems, drug interactions, chronic alcoholism, and vitamin deficiencies. Psychiatric disorders such as depression can masquerade as dementia as well.

The Alzheimer's Association acknowledged that FDA approval of florbetapir is a "double-edged sword," although it supports the move.

...the fact that all of the potential uses of this product are not crystal clear tempers our enthusiasm.

In a statement, the Association said that although the approval will expand the clinical and research opportunities for amyloid imaging, "the fact that all of the potential uses of this product are not crystal clear tempers our enthusiasm." Additional research is needed to clarify the role of florbetapir-PET imaging in Alzheimer's, it added.

Worried Well

Physicians weighing in agreed that amyloid measurements alone are not enough — that other imaging tests, including MRI, should also be part of the diagnostic equation. Many talked about the "multi-modal use" of this and other emerging amyloid biomarkers.

And, as Dr. Brewer pointed out, the new amyloid tracer does not measure tau, which some experts believe plays a crucial role in AD. Another agent under development by researchers at the University of California, Los Angeles, called FDDNP, images both tau and amyloid on PET.

All doctors also emphasized the importance of patient counseling before ordering an amyloid test.

"You have to have a good understanding of how that's going to influence discussions with the patient, and your treatment and prognostic decision-making," said Dr. Fleisher. He added that the test results could be quite anxiety provoking for a patient.

Doctors who spoke to Medscape Medical News also expressed a concern about "direct to patient" advertising and about "worried well" patients asking for this test. Many called for caution about using this new biomarker in cognitively normal patients who are anxious about their amyloid status.

The Alzheimer's Association, too, warns of "less than scrupulous" imaging operators who make unrealistic promises to such patients about the value of florbetapir imaging. It recommends that the test be accessible only in the context of a complete evaluation of medical/neurologic status and with appropriate expert consultation.

Cost Issues

Cost may be a significant issue in determining whom to scan using this new biomarker, doctors agreed. The price tag for the radioactive compound alone appears to be in the neighborhood of $1600, said Dr. Apostolova.

"Then there will be the added cost of getting the PET scan which in most places will be between $1000 and $1500. So I think we are looking at a cost of about $2500 to $3000 per scan here."

Because the tracer will be costly, "we have to use it with caution and only when it's really necessary,' said Dr. Apostolova, "Is it going to tell me anything beyond what I already know?"

As for insurance coverage, Dr. Petersen said that it's unclear at this time who will pay for this new agent when it becomes available in June. Dr. Knopman commented that that "to start with, no insurer will pay for it." The agent is also not currently eligible for coverage by the Centers for Medicare and Medicaid Services (CMS) because of its specific policy on reimbursement for PET procedures.

During a press conference after approval of the agent, Stephanie Prodouz, manager of Eli Lilly Bio-Medicines Communications, said that, "Although Amyvid will not be eligible for coverage, it's important to note that Lilly is working with a broad group of stakeholders to explore and collaborate with CMS to find a new policy for PET coverage."

Treatment Lacking

Although there is palpable excitement among some neurologists about the diagnostic possibilities of this new tracer, their enthusiasm is also tempered by the lack of available AD treatments.

"From a scientific viewpoint, the development of amyloid imaging was huge [but] the commercial availability is less so, unless it can be tied to finding better therapeutics," said Dr. Knopman. "Until there are better therapeutics for AD, amyloid imaging does not change the landscape in clinical practice."

Until there are better therapeutics for AD, amyloid imaging does not change the landscape in clinical practice.

But new treatments are on the horizon, according to Marwan Sabbagh, MD, director, Banner Sun Health Research institute, Sun City, Arizona. "Later this year, you will see 2 large immunotherapy studies — bapineuzumab and solanezumab — reporting their data to the world on their phase 3 trials, so the game changing elements here are perfectly timed in anticipation of these potential disease modifying agents."

Bapineuzumab and solanezumab are both monoclonal antibodies that bind to and clear beta amyloid. Dr. Sabbagh is an investigator on both trials and serves on the steering committee for the bapineuzumab study.

Still, it's unclear what role the amyloid plays and whether clearing it will result in any change in cognitive status. However, if safe and effective treatments become available, "that changes the whole ball game," commented Dr. Brewer.

Dr. Apostolova agreed. "If we can find an agent that can halt the disease progression, before symptoms occur, this [florbetapir] will become the single most useful diagnostic and prognostic test out there," she added.

For his part, Dr. DeKosky said that if an effective AD drug were available, the amyloid test could be used not necessarily to rule out AD but to determine that the cognitive impairment a patient experiences is indeed AD, so that drug could be administered.

Still, even in the absence of more effective amyloid treatments, many doctors felt that the test could nevertheless be useful. For example, said Dr. Brewer, it provides physicians with an opportunity to educate patients, help them manage risk factors and perhaps get them enrolled in a clinical trial.

As well, said Dr. Apostolova, the test results may spur patients to make necessary work-related arrangements or put their personal affairs in order. "Knowledge is power," she said.

Clinical Studies

According to Eli Lilly, the information on scans using the new tracer correlates highly with what is seen on autopsy. In a study that used the majority interpretation of 5 readers, there were 96% sensitivity and 100% specificity in patients who underwent scanning within a year of death.

Dr. Black called this autopsy correlation research "elegant." "It showed that indeed they were really picking up the amyloid" prior to death in these patients, she said.

The clinical studies also showed that the new diagnostic tracer appears to be very safe. The most common adverse reactions reported in these trials were headache (1.8%), musculoskeletal pain (0.8%), fatigue (0.6%), nausea (0.6%), anxiety (0.4%), back pain (0.4%), increased blood pressure (0.4%), claustrophobia (0.4%), feeling cold (0.4%), insomnia (0.4%), and neck pain (0.4%).

The studies are outlined in more detail in the product prescribing information.

But although the new imaging agent is safe and promises to be helpful diagnostically, training of interpreters will be key. Florbetapir was approved only with the proviso that Eli Lilly improve education initiatives for readers of the images. In January 2011, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13 to 3 against recommending approval for the tracer, but in a second unofficial vote, the committee voted 16 to 0 in favor of approval if the company would agree to structured training for those reading the scans.

"There was a fear that radiologists would not know how to interpret the scans, as well as a concern about what would be an appropriate use of this agent," said Dr. Black.

After working with the FDA and nuclear medicine experts, Eli Lilly developed both an online and an in-person training program for physicians. According to the company, images should be interpreted only by readers who have successfully completed a training course. The company cautions that errors may occur in the estimation of plaque density during image interpretation.

"This is a new kid on the block; it's a new technique" that requires training, commented Dr. Apostolova, who carries out imaging research. "It's not the case that one day, all of a sudden, one's brain's tissue becomes full of amyloid. It's a slow protracted continuous build up."

Patients will fall on a continuum, with some having minimal amyloid binding and others moderate or severe amounts, she added. "The last ones would be the easiest to call, but there will be many intermediate cases where we have to decide on a threshold that we will be using to call a scan positive versus calling it negative."

Not Straightforward

The lack of familiarity in reading scans could pose "a big problem" for clinicians since "it's not straightforward," commented Dr. Petersen.

Dr. Knopman agreed, saying he's "very concerned" about the scan interpretation issues. "I am dubious that radiologists who don't do a lot of them will misinterpret them," he said. "Even after nuclear medicine physicians have taken the course provided by Lilly, if they have low instances of contact with the test, they are likely to make mistakes in interpretation."

He added that he's particularly worried about the risk for overdiagnosis of Alzheimer's, especially when the amyloid imaging is not interpreted in light of the clinical history.

"For example, up to 30% of cognitively normal people over age 70 years are expected to have a 'positive' scan," he said. "I'm worried that a normalperson will hear that their amyloid scan shows 'Alzheimer's disease' and will conclude that they have the disease and are at imminent risk of losing their memories. In fact, an abnormal amyloid scan should be interpreted as showing amyloidosis, not Alzheimer's."

Dr. Black said her "hunch" is that florbetapir will be more likely to be used in specialty memory clinics that have access to experts who can properly interpret the scans than in general family practices.

Longer Half-Life

One of the advantages of the new agent is its versatility. Florbetapir has a half-life of almost 2 hours, compared to a half-life of 20 minutes for the currently available amyloid imaging agent, carbon 11–labeled Pittsburgh compound B (C-PiB).

The discovery of PiB was truly ground-breaking and set the stage for the current series of amyloid tracers now hitting the market, said Dr. DeKosky, who led the clinical trials of PiB.

"PiB was 7 years ahead of all these others," he said. "We were able to find a way to non-invasively detect amyloid in living people harmlessly, and then several people found a way to develop different compounds. They are all to be congratulated, but the first one is always the one for which there's romance," he says wryly.

But because even florbetapir still loses over half of its radioactivity every 2 hours, it must be distributed in a timely fashion from a radiopharmacy to an imaging center. To address this problem, Siemens PETNET Solutions, a subsidiary of Siemens Medical Solutions USA Inc, announced last week a manufacturing and distribution agreement with Eli Lilly.

Beginning in June, Siemens will supply florbetapir to imaging centers in limited US markets. By the end of the year, the company anticipates having 25 manufacturing centers and co-located radiopharmacies offering the compound.

Dr. Apostolova pointed out that to administer florbetapir, a center must also have a PET scanner. In addition to the manufacturing and distribution of florbetapir, Siemens announced its new Biograph mCT PET/CT (computed tomography) scanner, and related software.

Many neurologists said they have faith that the distribution network used by Lilly/Avid will make the agent widely available to clinicians.

"Now we have PET scanners everywhere, which we didn't have maybe 7 or 8 years ago," Dr. Black noted. "And now we have an 18-fluorine compound and there are others that should be emerging soon."

This widening and promising landscape, she said, "is very exciting."

Dr. Knopman is the chair of a data safety board for a Lilly anti-Alzheimer drug and as such receives compensation from Lilly. He has no relationships with any competitors of the Lilly amyloid imaging agent. Dr. Petersen is a consultant for GE Healthcare, which has an unapproved F18 agent. Dr. Apostolova has disclosed no relevant financial relationships; however, she will in the near future be contracted by Lilly to train the imaging community how to read Amyvid scans. Dr. DeKosky has disclosed no relevant financial relationships; he consulted for Eli Lilly but before that company bought Avid. Dr. Black has no current conflict with the makers of florbetapir or any other amyloid compound, although she is a site primary investigator in the Alzheimer's Disease Neuroimaging Initiative (ADNI) study, which is using the florbetapir ligand.

Medscape Medical News © 2012 WebMD, LLC