深圳搶金 買380萬被當散客 多市掀買金熱 東北商南下掃貨
(明報)2011年2月25日 星期五
【明報專訊】據內地媒體報道，內地多個城市近期出現黃金搶購潮，民眾排隊爭購黃金首飾和金條。有東北的「金老闆」更直接南下深圳 入貨，就算一次過買10公斤（約值380萬元人民幣）也只能算是「散客」。而在中國黃金產量第一的山東省，當地有黃金市場每天剛將黃金擺進櫃台就被搶購一空。
Gold Jewelry
「你根本沒有選的餘地，只能搶購。」《新文化報》引述長春金飾店老闆李京說，他和助手到深圳水貝市場入貨，「原來每次都是空運幾公斤黃金飾品，現在情况變了，你買不買對於加工廠來說眼睛都不眨一下，即使一次性將成交12公斤的買賣，在他們的眼裏也只能算是小客戶。」
山東金市 未進櫃台即搶光
「我們的採購地主要集中在深圳、北京 和上海 ，前幾年都是加工廠搶著聯繫我們，現在改了，我們得和加工廠搞好關係，否則就沒貨，現在各地金店老闆都在四處囤金。」李京說，此行先要打電話溝通，再和一間加工廠的銷售經理先疏通關係，才買夠12公斤黃金飾品。據資料顯示，深圳是中國最大的黃金加工基地，有2000多間黃金加工廠，進出口總量佔全國的1/3。
而據中央電視台報道，在山東省濰坊市昌樂縣的黃金市場「寶石城」，每天早上8點，黃金還來不及擺進櫃台就搶購一空，購買者不管是金條還是首飾，見貨就買，批發均價已上漲到每克303元人民幣，接近2010年的歷史最高位310元，但每天新加工的供應量遠遠不能滿足需求。
批發均漲至每克303元
《中國企業家》報道，自2002年中國開放黃金交易開始，金價已上漲了6倍，幾乎所有參與者都賺到錢，從未聽過有黃金交易公司倒閉，只有不斷新開張。據世界黃金協會統計，2010年第三季度中國投資金條的銷售比2009年增長了64%，破紀錄地達到45.1噸。
不過內地黃金市場存在大量灰色地帶，公安部統計，全國共有7000間地下炒金公司，號稱代理「倫敦 金」、「香港金」，其實是吸引民眾用50至100倍的槓桿來購買黃金投資產品，蝕了錢就卷款潛逃。但現時並無針對黃金市場的專門法規，所以良莠不齊的投資公司仍然大量存在。
2011-02-25
facebook 分手通知 Breakup Notifier 提你心上人情變
fb「分手通知」 提你心上人情變
(明報)2011年2月23日 星期三
【明報專訊】社交網站facebook周日推出應用程式「分手通知」（Breakup Notifier），使用後便可第一時間通過電郵得知心儀對象的戀愛狀態改變。對於一些苦等對方分手，想乘虛而入的人來說，它簡直是幫了大忙，因為他們不再需要每天密切注視意中人在facebook上的狀態變化。新app推出不足24小時內，已吸引逾10萬名用家使用。
自動電郵提示 方便乘虛而入
使用者登錄facebook後只需在朋友清單中選擇對象即可，這些人一旦關係狀態（status）改變，系統便會發送電郵提示用家，讓你及時在對方分手的落寞時候，提供「哭泣的肩膀」乘虛而入。
Lavalife
新app口號直接了當：「你喜歡某人。他們在戀愛中。成為首個知道他們失戀的人。」開發者勒文赫茨（Dan Loewenherz）透露，自己是在聽未婚妻與她母親聊天時獲啓發，當時準岳母想撮合另一未婚女兒與一名已有對象的男士，準岳母開玩笑道，若是能知道他什麼時候失戀就好了。
「分手通知」每24小時檢查戀愛狀態的改變。勒文赫茨有一些安全溫馨提示，例如若某人狀態顯示為已婚，可能就不建議將其列為關注對象了。該程式使用了Google的App Engine提供電郵服務，監測戀愛狀態則採用Django與facebook Graph API。
YCombinator網站上有人發帖稱「這是所看過最無意義、最微不足道、最可笑和可怕的程式」。但也有人稱這是個「偉大的想法」並稱和愛侶就是透過「分手通知」提示開始關係。
勒文赫茨表示，這個app很大程度只為好玩，但用家大可享受其中樂趣。過往有心理學研究顯示，過分沉迷facebook可能會發展為「facebook相關焦慮症 」。
每日郵報/PCMagzine/赫芬頓郵報
(明報)2011年2月23日 星期三
【明報專訊】社交網站facebook周日推出應用程式「分手通知」（Breakup Notifier），使用後便可第一時間通過電郵得知心儀對象的戀愛狀態改變。對於一些苦等對方分手，想乘虛而入的人來說，它簡直是幫了大忙，因為他們不再需要每天密切注視意中人在facebook上的狀態變化。新app推出不足24小時內，已吸引逾10萬名用家使用。
自動電郵提示 方便乘虛而入
使用者登錄facebook後只需在朋友清單中選擇對象即可，這些人一旦關係狀態（status）改變，系統便會發送電郵提示用家，讓你及時在對方分手的落寞時候，提供「哭泣的肩膀」乘虛而入。
Lavalife
新app口號直接了當：「你喜歡某人。他們在戀愛中。成為首個知道他們失戀的人。」開發者勒文赫茨（Dan Loewenherz）透露，自己是在聽未婚妻與她母親聊天時獲啓發，當時準岳母想撮合另一未婚女兒與一名已有對象的男士，準岳母開玩笑道，若是能知道他什麼時候失戀就好了。
「分手通知」每24小時檢查戀愛狀態的改變。勒文赫茨有一些安全溫馨提示，例如若某人狀態顯示為已婚，可能就不建議將其列為關注對象了。該程式使用了Google的App Engine提供電郵服務，監測戀愛狀態則採用Django與facebook Graph API。
YCombinator網站上有人發帖稱「這是所看過最無意義、最微不足道、最可笑和可怕的程式」。但也有人稱這是個「偉大的想法」並稱和愛侶就是透過「分手通知」提示開始關係。
勒文赫茨表示，這個app很大程度只為好玩，但用家大可享受其中樂趣。過往有心理學研究顯示，過分沉迷facebook可能會發展為「facebook相關焦慮症 」。
每日郵報/PCMagzine/赫芬頓郵報
成龍徐靜蕾網談風月 笑對激吻風波
成龍徐靜蕾網談風月 笑對激吻風波
(明報)2011年2月24日 星期四
【明報專訊】成龍 與有才女之稱的徐靜蕾 在飯局後，於車廂激吻道別，成為娛樂圈最新話題。不過兩個當事人一於懶理外界議論紛紛，成龍繼續拒絕回應「激吻風波」，與徐靜蕾同樣在微博只談風花雪月，徐靜蕾則透過經理人再次澄清只是朋友聚會，有工作人員陪同，兩人僅是GoodBye Kiss吻額，而不是激吻。
成龍車廂吻徐靜蕾照片在網上流傳後，大家都在討論成龍有否再犯不應犯的事？事件中的兩個主角昨日未有親自發言。
突「現身」微博評油畫
不過近期已少有在微博露面的成龍，昨午卻突然「現身」，並對王力宏 在微博上載的一幅畫發表回應﹕「很想房先生喜歡的照片呀！」該幅油畫是一幅嬉皮笑臉的油畫，不知是否當中含意是笑罵由人？該油畫作品為當代藝術家岳敏君作品，他畫作形象鮮明突出，深受歡迎，成龍看畫就想起自己兒子房祖名 ，一向望子成龍的他，是否也希望他的小房子（房祖名）也懂得欣賞中國文化藝術？雖然不少fans在微博中留言關心及支持成龍，但仍希望他回應一下激吻風波，但成龍一於「隱身」，未有回覆。
PerfectMatch
談做瑜伽 身心舒暢
至於徐靜蕾前日在微博形容今次事件是個冷笑話之後，昨日就索性在微博大講做45分鐘瑜伽身心舒暢，同樣不再回應事件；不過其經理人公司發言人則代徐靜蕾澄清，指當晚徐靜蕾只是出席朋友聚會，有工作人員陪同。發言人段小姐說，徐靜蕾和成龍未有任何親密關係，僅是離開時，成龍禮貌式送上車並吻額頭，作為道別之吻，並未有肉緊激吻，兩人近期亦沒有什麼合作計劃，希望事件早點結束。
GoodBye Kiss吻額定吻嘴？
昨日網上更有一段當時激吻風波發生的過程片段，亦見到成龍送徐靜蕾上車後，他伸頭入車厢捧住對方臉頰吻下去，但因為鏡頭有點矇，看不清楚是吻額還是嘴，不過一吻後，成龍就已站直身子，兩人揮手拜拜，想不到一個GoodBye Kiss發生在惹火的成龍身上，就一發不可收拾了。
記者﹕娛樂組
(明報)2011年2月24日 星期四
【明報專訊】成龍 與有才女之稱的徐靜蕾 在飯局後，於車廂激吻道別，成為娛樂圈最新話題。不過兩個當事人一於懶理外界議論紛紛，成龍繼續拒絕回應「激吻風波」，與徐靜蕾同樣在微博只談風花雪月，徐靜蕾則透過經理人再次澄清只是朋友聚會，有工作人員陪同，兩人僅是GoodBye Kiss吻額，而不是激吻。
成龍車廂吻徐靜蕾照片在網上流傳後，大家都在討論成龍有否再犯不應犯的事？事件中的兩個主角昨日未有親自發言。
突「現身」微博評油畫
不過近期已少有在微博露面的成龍，昨午卻突然「現身」，並對王力宏 在微博上載的一幅畫發表回應﹕「很想房先生喜歡的照片呀！」該幅油畫是一幅嬉皮笑臉的油畫，不知是否當中含意是笑罵由人？該油畫作品為當代藝術家岳敏君作品，他畫作形象鮮明突出，深受歡迎，成龍看畫就想起自己兒子房祖名 ，一向望子成龍的他，是否也希望他的小房子（房祖名）也懂得欣賞中國文化藝術？雖然不少fans在微博中留言關心及支持成龍，但仍希望他回應一下激吻風波，但成龍一於「隱身」，未有回覆。
PerfectMatch
談做瑜伽 身心舒暢
至於徐靜蕾前日在微博形容今次事件是個冷笑話之後，昨日就索性在微博大講做45分鐘瑜伽身心舒暢，同樣不再回應事件；不過其經理人公司發言人則代徐靜蕾澄清，指當晚徐靜蕾只是出席朋友聚會，有工作人員陪同。發言人段小姐說，徐靜蕾和成龍未有任何親密關係，僅是離開時，成龍禮貌式送上車並吻額頭，作為道別之吻，並未有肉緊激吻，兩人近期亦沒有什麼合作計劃，希望事件早點結束。
GoodBye Kiss吻額定吻嘴？
昨日網上更有一段當時激吻風波發生的過程片段，亦見到成龍送徐靜蕾上車後，他伸頭入車厢捧住對方臉頰吻下去，但因為鏡頭有點矇，看不清楚是吻額還是嘴，不過一吻後，成龍就已站直身子，兩人揮手拜拜，想不到一個GoodBye Kiss發生在惹火的成龍身上，就一發不可收拾了。
記者﹕娛樂組
第三大產油國利比亞大亂石油供應急降 期油價金價「坐火箭」
利比亞大亂 油金「坐火箭」
(星島)2011年2月25日 星期五
(綜合報道)
(星島日報 報道)國際油價連續第四日攀升，倫敦 期油價昨日逼近每桶百二美元 ，創三十個月新高；紐約 期油也兩年半以來首度重越每桶一百美元水平，反映非洲 第三大產油國利比亞石油供應急降，且市場擔心該國亂局有蔓延至其他中東產油國之虞，刺激油價飆升。金價也續創七周高位，瑞郎和日圓 的避險地位也進一步增強，兌美元分別創紀錄高位和兩周新高。
本報財經組
承接之前三個交易日的升勢，四月份倫敦布蘭特原油期貨價格昨日高位曾攀上每桶一一九點七九美元，升百分之七點六八，為○八年八月以來最高。紐約四月期油價格也步入第三日升勢，曾高見每桶一○三點四一美元，升百分之五點四一，亦創逾兩年半新高。
期油破百 金見1418
現貨金價昨天續升，一度上揚至每盎司一四一八點二美元，升百分之零點四六，為一月三日以來新高。
Auto Insurance
匯價方面，市場憂慮中東政局不穩，瑞郎和日圓繼續受追捧。在連跌兩日後，美元昨天續挫，曾低見零點九二四一瑞郎（瑞郎兌八點四二九港元）的紀錄低位，跌百分之零點九五；美元兌日圓也步入連續第七個交易日下跌，曾低見八十一點七一日圓（每百日圓兌九點五三三港元），跌百分之零點九七，為二月四日以來新低。三菱UFJ信託的外匯及金融交易部經理塚田表示，中東形勢化在惡化，投資者紛紛避險，資金湧進日圓和瑞郎，刺激該兩種貨幣匯價急升。
瑞郎日圓創新高
此外，加息前景的推動下，歐羅 兌美元續升，昨日高位曾見一點三八○八美元（兌十點七五六四 港元），升百分之零點四三，為二月三日來最高位；歐羅兌日圓則下挫，曾滑落至一一二點一九日圓，跌百分之一點一。
日減產40萬桶
利比亞是非洲第三大產油國以及全球第十二大石油出口商，目前擁有非洲最大油儲量。據路透社估算，該國局勢惡化前每日石油產量一百六十萬桶，現時每日下降最少四十萬桶，即兩成半。能源公司ENI更估計利比亞的每日減產數目為一百二十萬桶。
高盛的分析師居里發表報告說，利比亞亂局有蔓延至沙特阿拉伯 等其他中東產油國之虞，最後可能導致全球石油嚴重緊絀，而問題在於石油輸出國組織（OPEC）的後備產能中，利比亞佔其半，該國石油供應大降，勢將扭曲全球石油市場。
(星島)2011年2月25日 星期五
(綜合報道)
(星島日報 報道)國際油價連續第四日攀升，倫敦 期油價昨日逼近每桶百二美元 ，創三十個月新高；紐約 期油也兩年半以來首度重越每桶一百美元水平，反映非洲 第三大產油國利比亞石油供應急降，且市場擔心該國亂局有蔓延至其他中東產油國之虞，刺激油價飆升。金價也續創七周高位，瑞郎和日圓 的避險地位也進一步增強，兌美元分別創紀錄高位和兩周新高。
本報財經組
承接之前三個交易日的升勢，四月份倫敦布蘭特原油期貨價格昨日高位曾攀上每桶一一九點七九美元，升百分之七點六八，為○八年八月以來最高。紐約四月期油價格也步入第三日升勢，曾高見每桶一○三點四一美元，升百分之五點四一，亦創逾兩年半新高。
期油破百 金見1418
現貨金價昨天續升，一度上揚至每盎司一四一八點二美元，升百分之零點四六，為一月三日以來新高。
Auto Insurance
匯價方面，市場憂慮中東政局不穩，瑞郎和日圓繼續受追捧。在連跌兩日後，美元昨天續挫，曾低見零點九二四一瑞郎（瑞郎兌八點四二九港元）的紀錄低位，跌百分之零點九五；美元兌日圓也步入連續第七個交易日下跌，曾低見八十一點七一日圓（每百日圓兌九點五三三港元），跌百分之零點九七，為二月四日以來新低。三菱UFJ信託的外匯及金融交易部經理塚田表示，中東形勢化在惡化，投資者紛紛避險，資金湧進日圓和瑞郎，刺激該兩種貨幣匯價急升。
瑞郎日圓創新高
此外，加息前景的推動下，歐羅 兌美元續升，昨日高位曾見一點三八○八美元（兌十點七五六四 港元），升百分之零點四三，為二月三日來最高位；歐羅兌日圓則下挫，曾滑落至一一二點一九日圓，跌百分之一點一。
日減產40萬桶
利比亞是非洲第三大產油國以及全球第十二大石油出口商，目前擁有非洲最大油儲量。據路透社估算，該國局勢惡化前每日石油產量一百六十萬桶，現時每日下降最少四十萬桶，即兩成半。能源公司ENI更估計利比亞的每日減產數目為一百二十萬桶。
高盛的分析師居里發表報告說，利比亞亂局有蔓延至沙特阿拉伯 等其他中東產油國之虞，最後可能導致全球石油嚴重緊絀，而問題在於石油輸出國組織（OPEC）的後備產能中，利比亞佔其半，該國石油供應大降，勢將扭曲全球石油市場。
2011-02-24
Macau Home Prices May Climb as Much as 20% as Casino Growth Fuels Demand
Macau Home Prices May Climb as Much as 20% as Casino Growth Fuels Demand
By Kelvin Wong - Feb 23, 2011
Macau home prices, which have recovered to pre-global credit crisis levels, may rise as much as 20 percent this year as the city’s economy benefits from an expanding casino industry.
Residential values in the world’s biggest gambling hub will gain 20 percent in 2011, according to Midland Holdings Ltd., Hong Kong’s largest publicly traded real estate agency. Jones Lang LaSalle Inc., the world’s second-biggest commercial property broker, predicts a 10 percent gain, while London-based Savills Plc forecasts a 15 percent jump.
Low interest rates, a lack of new supply and rising personal incomes driven by a 58 percent surge in casino revenue helped real estate prices in the former Portuguese colony in southern China climb 15 percent in 2010 even as the government introduced measures to stamp out speculation.
“The property market is now being supported by locals whose incomes have risen off the casino boom, and also the huge demand for rental from foreign workers coming in for the new casinos and other infrastructure projects,” said Gregory Ku, managing director for Macau at Jones Lang.
Casino revenue in Macau may climb 30 percent to $30 billion this year as visitors from mainland China increase, CLSA Ltd. said in a report last month. China contributed more than half the number of Macau’s 25 million tourist arrivals last year.
Macau’s casino revenue grew to more than four times that of the Las Vegas Strip after the government allowed the entry of overseas operators in 2002, including Las Vegas Sands Corp., the world’s biggest casino company by market value, and Wynn Resort Ltd., ending billionaire Stanley Ho’s four-decade monopoly.
Local Investors
Prices for some luxury projects, such as the One Central Macau Residences co-developed by Ho’s Shun Tak Holdings Ltd. and Hongkong Land Holdings Ltd., have risen to about 6,000 patacas ($748) to 7,000 patacas a square foot at the end of last year from about 4,000 patacas in early 2009, according to Jones Lang.
About 10 percent of those who bought the properties last year were foreign investors, compared with about 35 percent between 2007 and 2008, said Ku.
“The credit crisis has pretty much driven out all the foreign funds looking to make a quick profit,” he said.
Galaxy Entertainment Group Ltd., the casino operator part- owned by Permira Advisers LLP, plans to hire as many as 8,000 workers this year after the opening of its 600-table casino in Macau’s Cotai district, Chief Financial Officer Robert Drake said Feb. 15. Macau, the only region in China where casinos are legal, has a population of 550,000.
Huge Demand
The city’s government is building a light-rail system aimed to be finished in 2014 and is working with neighboring Hong Kong and Zhuhai to build a bridge connecting the three cities.
“People are earning more and that’s creating a huge demand to upgrade to better properties,” said Franco Liu, managing director for Savills’s Macau unit. “With limited new land supply in the next few years, there’s so much pressure on prices to keep going up.”
Prices of some luxury apartments have risen as much as 80 percent from the trough during the credit crisis, prompting the government last year to impose higher property transaction taxes and raise mortgage down payments for transactions larger than 3.3 million patacas.
That may lead luxury prices to lag “slightly behind” those in the mass market this year, said Savills’s Liu.
“The measures may push some buyers to shift to lower value properties because they can get a higher mortgage and fall into a lower tax brackets,” he said.
Luxury Prices
With no standard definition for Macau luxury prices, property agencies normally distinguish them from those in the broader market based on location and prices, said Stanley Poon, managing director for Macau at Centaline Property Agency Ltd., Hong Kong’s biggest closely held realtor. Centaline forecasts Macau home prices to rise 15 percent in 2011.
Macau’s luxury home prices fell as much as 40 percent in early 2009 from a previous height in 2007, according to Centaline, after several foreign funds sold investments and developers halted projects as liquidity dried up during the credit crisis.
The number of property transactions fell to 17,000 in 2009, a seven-year low, before rebounding to 30,000 last year, according to data from the Macau government.
Macau’s economy may rise 26 percent in 2010 from a year earlier, according to a forecast by Secretary of Economy and Finance Francis Tam. The jobless rate of 2.7 percent in the fourth quarter was the lowest since 1999, according to government statistics.
Limited Supply
About 80 percent of Macanese own their homes, whose values are still at “a substantial discount” to properties in Hong Kong, about an hour by ferry, said Tom Ashworth, fund manager for Macau Property Opportunities Fund Ltd., which has about $333 million in assets and is developing residential projects including the Fountainside in Macau. Hong Kong home prices have surged about 60 percent in the past two years.
“That gap’s got to close,” Ashworth said. “It’s not going to go to parity, but we believe the current 70 percent discount to Hong Kong could definitely narrow to maybe 50 percent.” Ashworth compared prices at One Central Macau and Hong Kong’s Bel-Air, a luxury apartment project in Hong Kong’s Island South district where units are selling at about HK$20,000 ($2,567) a square foot.
Approval for new real estate and infrastructure projects has slowed since the jailing of a former senior government official in 2008 that sparked a series of anti-graft measures by the government, said Ronald Cheung, managing director for Macau at Midland.
About 2,500 new apartments in projects including the One Grantai and The Riviera Macau are expected to be completed in 2011, down from 3,400 in 2010, he said. Annual completion will probably fall below 1,000 in each of 2012 and 2013 before rebounding in 2014.
“This two-year gap will continue to push up both rents and prices for new units,” Cheung said. “Buyers are also mindful of the threat of inflation that’s driven by the low interest rates,” which are near 20-year low, he said.
香港政府注資強積金 每人六千
政府注資強積金 每人六千
(明報)2011年2月23日 星期三
財政司 長曾俊華 宣布，向所有擁有強積金 的市民，一次過派發6000元，注入他們的強積金戶口。
曾俊華在財政預算案中表示，為增加強積金和職業退休計劃成員的退休儲蓄，建議為所有在今年2月23日已成為強積金計劃或職業退休計劃下，受香港《僱傭條例 》涵蓋的成員的人士，向他們的強積金戶口一次過注入6,000元。
Wall Street Journal Online
他指，這次的注資建議不設收入上限，希望協助更多市民為退休作好準備。這既不會增加通脹壓力，也是政府現在財政上可負擔的。
他表示，已經為這項措施預留240億元。財經事務及庫務局 稍後會公布詳情，積金局 會協助執行注資工作。他希望在2011至12年度內，開始向有關的強積金戶口注入款項。
（即時新聞）
(明報)2011年2月23日 星期三
財政司 長曾俊華 宣布，向所有擁有強積金 的市民，一次過派發6000元，注入他們的強積金戶口。
曾俊華在財政預算案中表示，為增加強積金和職業退休計劃成員的退休儲蓄，建議為所有在今年2月23日已成為強積金計劃或職業退休計劃下，受香港《僱傭條例 》涵蓋的成員的人士，向他們的強積金戶口一次過注入6,000元。
Wall Street Journal Online
他指，這次的注資建議不設收入上限，希望協助更多市民為退休作好準備。這既不會增加通脹壓力，也是政府現在財政上可負擔的。
他表示，已經為這項措施預留240億元。財經事務及庫務局 稍後會公布詳情，積金局 會協助執行注資工作。他希望在2011至12年度內，開始向有關的強積金戶口注入款項。
（即時新聞）
2011-02-23
What we still don't know about Lasik
Elective Surgery
WEDNESDAY, FEB 16, 2011
What we still don't know about Lasik
As the surgery continues to plague patients like me, the man who approved it for the FDA pushes for a recall
BY ABBY ELLIN
Salon
How are your eyes?
That's all anyone ever wants to know these days: How my eyes are doing after my collision with Lasik almost three years ago. Are they still dry? Do they still hurt when exposed to sunlight? Is my vision still blurred? And what about glasses -- am I still wearing them?
The answer: Yes, yes, yes and yes. Emphatically, resoundingly, blindingly yes. My eyes sting. They burn. I look at neon signs and the colors bleed into a fluorescent Rorschach test. I have difficulty deciphering black lettering on white boards; I have personally helped elevate the stock of Allergan, which manufactures Refresh Plus, the drops that allegedly help dry eye.
Lasik Hong Kong
Clearly, this is all very annoying, but at this point, I'm used to it. It's just one of the things I live with, like PMS and hangnails. And in the grand scheme of things, it's not so bad. According to Market Scope, LLC, an ophthalmic industry research firm, nearly 15 million procedures have been performed in the U.S. over the last decade, with a 95.4 percent patient satisfaction rate. Lasik is also a $1.6 billion industry -- which, as Michael Lewis points out in "The Big Short," was initially created to replace the revenue stream lost to declining cataract surgery reimbursement rates.
Ninety-five percent satisfaction is not awful (although of course it depends on what your definition of "is" is). It's the other 5 percent that worries me. I've interviewed people who've had corneal transplants because of botched Lasik, who've lost their jobs because they can't see -- like Los Angeles Dodger Jay Gibbons, who reportedly stopped playing winter ball in Venezuela because of blurred vision he acquired after Lasik surgery earlier in the season, the L.A. Times reported.
So all in all, I'm pretty lucky. But I think it's fair to say that I'm angry. Not just about my situation, but because this is an industry where it's almost impossible to find a reputable refractive surgeon to speak out on behalf of patients. If you've got a problem, it's your fault. I went to a dry eye specialist in New York City, a guy who wrote a book on the subject. He acknowledged that Lasik causes dry eye and that it's a major surgical side effect.
"Would you ever say that on the record?" I asked.
He shook his head somewhat sheepishly. "We do Lasik here," he explained. Aha! Talk about a smart businessman. He's got the problem and the solution under one roof.
Attorneys also have trouble finding doctors to testify for patients. On June 2, 2009, Todd Krouner, a lawyer in Chappaqua, N.Y., who has won millions of dollars for injured Lasik patients, cross-examined a Dr. Wing Chu in a case involving a patient with post-Lasik ectasia, a bulging of the cornea. Dr. Chu is medical director of the Eye-Bank for Sight Restoration, and an associate clinical professor of ophthalmology at Columbia University, among other appointments. He was hired by the defense to conduct an independent medical examination of the patient. Here's how that conversation went:
Krouner: "Is your version of the Hippocratic oath "first do no harm" translated "first do no harm to any ophthalmologist," is that your interpretation of the Hippocratic oath?"
Chu: "That's a part of it."
Oh. Good to know.
The hero here is a man named Morris Waxler, whom I wrote about last year for Salon. Waxler is a Ph.D. and a former branch chief of the FDA's Center for Devices and Radiological Health from 1995 to 1999. He was, in effect, the man responsible for approving Lasik vision enhancement lasers in 1997. Since that time, he has become rabidly anti-Lasik, publicly admitting that the FDA "screwed up" when it approved it.
Now he's taken his activism a step further. Last month, he filed a petition calling for the FDA to withdraw approval "for all Lasik devices and issue a Public Health Advisory with a voluntary recall of Lasik devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for Lasik eye surgery."
In his petition, Waxler maintains that the initial approval was based on data that was "dominated by Lasik surgeons working hand-in-glove with Lasik manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of Lasik devices were the device manufacturers and its collaborators." Consequently, he says, the FDA was deprived of knowledge of the full extent of Lasik injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of Lasik devices.
He adds that -- contrary to the FDA's own device-approval standard, which limits adverse events to 1 percent -- published scientific data shows that Lasik devices induce an average adverse event rate of about 22 percent "that persists beyond six months to five or more years."
Lastly, he says, the published data shows that Lasik devices transform healthy corneas into sick corneas that never completely heal; are permanently weakened, vulnerable to trauma and inflammation; cause neuropathic dry eyes; have pathology that progresses annually; are vulnerable to blinding corneal bulging (keratectasia); compromise night vision; have unstable vision corrections that regress; and require eye care that otherwise wouldn't be needed.
This is potent stuff. And it doesn't seem to be the rantings of a bored retiree. "The idea that I had such a hand in getting a product on the market that was messing people's eyes up is disgusting," he says. "My wife said, 'Why are you getting back into that mess? Leave it to other people.' But I couldn't leave it alone. The more I discovered about it, the worse it got. Rereading the applications to the FDA that I once read and reviewed and reviewing the published literature since then -- it's not a pretty picture."
It's not a pretty picture, but it seems to be pervasive among the FDA. According to a recent report in the Archives of Internal Medicine, of the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks or even death, more than 70 percent had been approved because they were considered similar to other products on the market. "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," the authors wrote.
While Waxler stops a centimeter short of using the C word (that would be, "conspiracy"), he does wonder why doctors failed to report adverse, or negative, reactions after five or six months. "They didn't report the data," he says. "They said patients wouldn't come back because as far as they could tell patients were doing very well. It's like asking Iran how many nuclear sites they have and them saying, 'We don't have any.' And saying, 'OK, that's fine. We trust you.'"
The refractive surgery community, not surprisingly, is less than pleased with Waxler. The American Society of Cataract and Refractive Surgery stated that while they laud his commitment to Lasik safety (which they share), they "disagree with his science and conclusions."
"The vast preponderance of clinical evidence shows that Lasik is safe and effective -- a conclusion that the FDA has repeatedly re-affirmed in its multiple reviews of up-to-date information," they wrote. "By failing to follow standard scientific protocol, Dr. Waxler does a disservice to all LASIK patients -- including those few who have had serious problems and who deserve to have them clearly understood."
After talking with Waxler, I called, and e-mailed, and called, and e-mailed again, the FDA to no response. Finally, Karen Riley, an FDA spokesperson, shot me an e-mail: "FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for Lasik," she wrote. "In October of last year we provided a brief update on our role in a three-part study of Lasik that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure."
It was a nice pat response, but had nothing to do with Waxler's petition. That response came from David S. Buckles, Ph.D., the ombudsman for the CDRH, and was forwarded to me by a Lasik activist:
"I personally appreciate the effort by Dr. Waxler and colleagues to use this approach to raise these issues with the Commissioner's Office because this is an appropriate venue within which to propose changes to the means by which Lasik devices are regulated," Buckles wrote. "While we in CDRH do not have close contact with proceedings in the Commissioner's Office on this particular matter, my understanding is that the petition is under review at the Commissioner's level to determine whether to accept the petition for consideration.
If the petition is accepted for consideration, and subsequently members of CDRH are tasked to participate in the review, then we will have some visibility into the process. However, until that happens, the status of the petition is not within our cognizance."
In other words: Let's wait and see. And wait some more.
Realistically, of course, it's unlikely that Lasik will be banned. Plenty of people have had tremendously wonderful experiences. Even Todd Krouner, the lawyer, says that he "knows and respects too many honest, intelligent, competent Lasik surgeons, who 'eat their own cooking' and have had Lasik themselves," he says. "Still, I believe that the public deserves an honest study, free from the bias and influence of the Lasik industry.
There are bright doctors and trustworthy public health officials who have no financial interest in Lasik, who are certainly qualified to perform a credible study. Without that, I doubt that the public will be able to assess the true risks, benefits and alternatives to Lasik surgery. If doctors cannot agree among themselves about the true incidence of ectasia, or much more common dry eye syndrome, how is a patient ever supposed to make a truly informed decision?"
How indeed? It's a good question, and one I'd like to explore further. But not right now. My eyes hurt.
Abby Ellin is the author of "Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help." Her website is AbbyEllin.com. She lives, works, and tries to see in New York City.
WEDNESDAY, FEB 16, 2011
What we still don't know about Lasik
As the surgery continues to plague patients like me, the man who approved it for the FDA pushes for a recall
BY ABBY ELLIN
Salon
How are your eyes?
That's all anyone ever wants to know these days: How my eyes are doing after my collision with Lasik almost three years ago. Are they still dry? Do they still hurt when exposed to sunlight? Is my vision still blurred? And what about glasses -- am I still wearing them?
The answer: Yes, yes, yes and yes. Emphatically, resoundingly, blindingly yes. My eyes sting. They burn. I look at neon signs and the colors bleed into a fluorescent Rorschach test. I have difficulty deciphering black lettering on white boards; I have personally helped elevate the stock of Allergan, which manufactures Refresh Plus, the drops that allegedly help dry eye.
Lasik Hong Kong
Clearly, this is all very annoying, but at this point, I'm used to it. It's just one of the things I live with, like PMS and hangnails. And in the grand scheme of things, it's not so bad. According to Market Scope, LLC, an ophthalmic industry research firm, nearly 15 million procedures have been performed in the U.S. over the last decade, with a 95.4 percent patient satisfaction rate. Lasik is also a $1.6 billion industry -- which, as Michael Lewis points out in "The Big Short," was initially created to replace the revenue stream lost to declining cataract surgery reimbursement rates.
Ninety-five percent satisfaction is not awful (although of course it depends on what your definition of "is" is). It's the other 5 percent that worries me. I've interviewed people who've had corneal transplants because of botched Lasik, who've lost their jobs because they can't see -- like Los Angeles Dodger Jay Gibbons, who reportedly stopped playing winter ball in Venezuela because of blurred vision he acquired after Lasik surgery earlier in the season, the L.A. Times reported.
So all in all, I'm pretty lucky. But I think it's fair to say that I'm angry. Not just about my situation, but because this is an industry where it's almost impossible to find a reputable refractive surgeon to speak out on behalf of patients. If you've got a problem, it's your fault. I went to a dry eye specialist in New York City, a guy who wrote a book on the subject. He acknowledged that Lasik causes dry eye and that it's a major surgical side effect.
"Would you ever say that on the record?" I asked.
He shook his head somewhat sheepishly. "We do Lasik here," he explained. Aha! Talk about a smart businessman. He's got the problem and the solution under one roof.
Attorneys also have trouble finding doctors to testify for patients. On June 2, 2009, Todd Krouner, a lawyer in Chappaqua, N.Y., who has won millions of dollars for injured Lasik patients, cross-examined a Dr. Wing Chu in a case involving a patient with post-Lasik ectasia, a bulging of the cornea. Dr. Chu is medical director of the Eye-Bank for Sight Restoration, and an associate clinical professor of ophthalmology at Columbia University, among other appointments. He was hired by the defense to conduct an independent medical examination of the patient. Here's how that conversation went:
Krouner: "Is your version of the Hippocratic oath "first do no harm" translated "first do no harm to any ophthalmologist," is that your interpretation of the Hippocratic oath?"
Chu: "That's a part of it."
Oh. Good to know.
The hero here is a man named Morris Waxler, whom I wrote about last year for Salon. Waxler is a Ph.D. and a former branch chief of the FDA's Center for Devices and Radiological Health from 1995 to 1999. He was, in effect, the man responsible for approving Lasik vision enhancement lasers in 1997. Since that time, he has become rabidly anti-Lasik, publicly admitting that the FDA "screwed up" when it approved it.
Now he's taken his activism a step further. Last month, he filed a petition calling for the FDA to withdraw approval "for all Lasik devices and issue a Public Health Advisory with a voluntary recall of Lasik devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for Lasik eye surgery."
In his petition, Waxler maintains that the initial approval was based on data that was "dominated by Lasik surgeons working hand-in-glove with Lasik manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of Lasik devices were the device manufacturers and its collaborators." Consequently, he says, the FDA was deprived of knowledge of the full extent of Lasik injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of Lasik devices.
He adds that -- contrary to the FDA's own device-approval standard, which limits adverse events to 1 percent -- published scientific data shows that Lasik devices induce an average adverse event rate of about 22 percent "that persists beyond six months to five or more years."
Lastly, he says, the published data shows that Lasik devices transform healthy corneas into sick corneas that never completely heal; are permanently weakened, vulnerable to trauma and inflammation; cause neuropathic dry eyes; have pathology that progresses annually; are vulnerable to blinding corneal bulging (keratectasia); compromise night vision; have unstable vision corrections that regress; and require eye care that otherwise wouldn't be needed.
This is potent stuff. And it doesn't seem to be the rantings of a bored retiree. "The idea that I had such a hand in getting a product on the market that was messing people's eyes up is disgusting," he says. "My wife said, 'Why are you getting back into that mess? Leave it to other people.' But I couldn't leave it alone. The more I discovered about it, the worse it got. Rereading the applications to the FDA that I once read and reviewed and reviewing the published literature since then -- it's not a pretty picture."
It's not a pretty picture, but it seems to be pervasive among the FDA. According to a recent report in the Archives of Internal Medicine, of the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks or even death, more than 70 percent had been approved because they were considered similar to other products on the market. "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," the authors wrote.
While Waxler stops a centimeter short of using the C word (that would be, "conspiracy"), he does wonder why doctors failed to report adverse, or negative, reactions after five or six months. "They didn't report the data," he says. "They said patients wouldn't come back because as far as they could tell patients were doing very well. It's like asking Iran how many nuclear sites they have and them saying, 'We don't have any.' And saying, 'OK, that's fine. We trust you.'"
The refractive surgery community, not surprisingly, is less than pleased with Waxler. The American Society of Cataract and Refractive Surgery stated that while they laud his commitment to Lasik safety (which they share), they "disagree with his science and conclusions."
"The vast preponderance of clinical evidence shows that Lasik is safe and effective -- a conclusion that the FDA has repeatedly re-affirmed in its multiple reviews of up-to-date information," they wrote. "By failing to follow standard scientific protocol, Dr. Waxler does a disservice to all LASIK patients -- including those few who have had serious problems and who deserve to have them clearly understood."
After talking with Waxler, I called, and e-mailed, and called, and e-mailed again, the FDA to no response. Finally, Karen Riley, an FDA spokesperson, shot me an e-mail: "FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for Lasik," she wrote. "In October of last year we provided a brief update on our role in a three-part study of Lasik that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure."
It was a nice pat response, but had nothing to do with Waxler's petition. That response came from David S. Buckles, Ph.D., the ombudsman for the CDRH, and was forwarded to me by a Lasik activist:
"I personally appreciate the effort by Dr. Waxler and colleagues to use this approach to raise these issues with the Commissioner's Office because this is an appropriate venue within which to propose changes to the means by which Lasik devices are regulated," Buckles wrote. "While we in CDRH do not have close contact with proceedings in the Commissioner's Office on this particular matter, my understanding is that the petition is under review at the Commissioner's level to determine whether to accept the petition for consideration.
If the petition is accepted for consideration, and subsequently members of CDRH are tasked to participate in the review, then we will have some visibility into the process. However, until that happens, the status of the petition is not within our cognizance."
In other words: Let's wait and see. And wait some more.
Realistically, of course, it's unlikely that Lasik will be banned. Plenty of people have had tremendously wonderful experiences. Even Todd Krouner, the lawyer, says that he "knows and respects too many honest, intelligent, competent Lasik surgeons, who 'eat their own cooking' and have had Lasik themselves," he says. "Still, I believe that the public deserves an honest study, free from the bias and influence of the Lasik industry.
There are bright doctors and trustworthy public health officials who have no financial interest in Lasik, who are certainly qualified to perform a credible study. Without that, I doubt that the public will be able to assess the true risks, benefits and alternatives to Lasik surgery. If doctors cannot agree among themselves about the true incidence of ectasia, or much more common dry eye syndrome, how is a patient ever supposed to make a truly informed decision?"
How indeed? It's a good question, and one I'd like to explore further. But not right now. My eyes hurt.
Abby Ellin is the author of "Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help." Her website is AbbyEllin.com. She lives, works, and tries to see in New York City.
Lasik's blurry vision
Elective Surgery
MONDAY, JAN 25, 2010
salon.com
Lasik's blurry vision
Side effects continue to plague patients like me. Now, as the FDA investigates, one expert admits, "We screwed up"
BY ABBY ELLIN
Lasik
The other day I got a prescription for eyeglasses. This is not newsworthy in itself except for one thing: More than two and a half years ago I had Lasik (laser-assisted in situ keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I knew that eventually I would need reading glasses, but I would, I was assured, be able to see long-distance for a long time.
Problem is, I can't.
Not only is my vision blurred, but as I wrote in a 2008 article for the New York Times, I still see halos, and not the kinds with angels attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms.
My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I signed an "informed consent" saying I understood all the possible side effects, but I certainly never knew that they might last indefinitely, and that they would be more than "annoying," as my doctor promised.
But nearly three years later, they are still here. And while I could get an "enhancement" -- that's industry parlance for another surgery to correct errors -- frankly, the only thing I want near my eyes is mascara.
According to the American Society of Cataract and Refractive Surgery, most of the 13.6 million people in the United States who have had Lasik surgery since the first lasers were approved by the FDA in 1998 are pleased with the results. But others have experienced similar, if not worse, problems than I have.
Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical "adverse events."
And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who've had laser vision correction surgeries are still wearing glasses or contacts some of the time.
Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.
Still, the American Society of Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies involving 2,022 patients that specifically addressed patient satisfaction.
"Based on everything we know from the literature, and everything I know from any other elective procedure, Lasik eye surgery is the most successful elective procedure performed," said Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a co-researcher on the study.
The experience of patients like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about four years ago, seem to support this assessment. Getting the procedure, he said, was one of the best decisions he has ever made. While he does experience some starbursts, he said "it’s not bothersome at all."
But the FDA and others are taking note of what they call "quality of life" issues. In October, the FDA, the Defense Department and the National Eye Institute announced in October a three-year effort to assess adverse effects of Lasik.
The effort will involve gauging how many active-duty military patients at the Navy Refractive Surgery Center in San Diego suffered post-surgical eye problems, and a series of national, multi-center clinical trials that will study the impact on quality of life following Lasik surgery in the general population. In addition, the FDA has reopened a public docket to receive comments through Nov. 15.
"We noted that there was little consistent evaluation of the issues," said Mary Long, an FDA spokeswoman, about the reasons for why the study was initiated.
Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. "Lasik is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those few of us who speak ill of it are dismissed as cranks and/or loonies," he wrote in an e-mail message. "I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost -- human and otherwise -- of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through."
Surf the Web and you can find dozens of stories from people who have had post-Lasik difficulties: dry-eye, halos, glare. Some complications have resulted in corneal transplants. Over the last few years patient activists have bombarded the FDA with anti-Lasik e-mails, complaints and petitions.
Among them is John Hoge, 39, a businessman in Port Jefferson, N.Y., who suffered from night glare and halos and regrets not choosing the "zero risk option" of corrective lenses. A few years ago he got some experimental contact lenses that have largely taken care of the glare issue. They are expensive, he added, and are not covered by insurance.
While the FDA's recent efforts have given some patient activists a modicum of peace, many do not feel it is enough. "By not inspecting every Lasik facility in this nation, how is the FDA to know if Lasik doctors are compliant?" said Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Fla., who has experienced double vision, starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web site LifeafterLasik.com.
Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. "We screwed up," said Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health Office of Science and Technology from 1995 to 1999. "You know how some drugs have a black box warning -- it’s dangerous because of this, this and this -- we could have done something comparable to that. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials."
Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Va., agreed. "It appears that information to provide adequate informed consent was not sufficient for all prospective patients about occasions where a bad outcome could result," he said. “The present dissatisfaction rate of 5 percent is very high. Personally and professionally, I am very disappointed in the FDA."
Spokeswoman Long refutes the notion that the FDA was errant. "The FDA has reviewed safety and effectiveness information included in the manufacturer’s applications for approval," she wrote in an e-mail message. "We found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health."
Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to Lasik ambulatory facilities last May reminding them that all risks must be mentioned in every Lasik advertisement online, in print, radio or TV.
"As part of our ongoing review of Lasik and its impact on public health, we continue to look at various aspects of Lasik advertising and how we can better improve public health," said Long.
Still, an informal online search showed dozens of doctors' Web sites that do not mention risks or side effects.
As for the new study, Larry Pilot is not impressed. "The FDA is beginning to do what should have been done 10 years ago," he said. "The bottom line here is that upwards of scores of thousands of human eyes have been irreversibly damaged unnecessarily."
Dr. Solomon disagreed, maintaining that the FDA clinical trials on Lasik lasers were "rigorous" and "well-performed." "I think the FDA did an outstanding job at evaluating the technology," he said. "And the technology and procedure since approval have only gotten better."
As for me, if I had to do it all over again I wouldn't. But hindsight, alas, is 20-20.
Abby Ellin is the author of " Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help ." She lives, works, and tries to see in New York City.
Abby Ellin is the author of "Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help." Her website is AbbyEllin.com. She lives, works, and tries to see in New York City. More:
MONDAY, JAN 25, 2010
salon.com
Lasik's blurry vision
Side effects continue to plague patients like me. Now, as the FDA investigates, one expert admits, "We screwed up"
BY ABBY ELLIN
Lasik
The other day I got a prescription for eyeglasses. This is not newsworthy in itself except for one thing: More than two and a half years ago I had Lasik (laser-assisted in situ keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I knew that eventually I would need reading glasses, but I would, I was assured, be able to see long-distance for a long time.
Problem is, I can't.
Not only is my vision blurred, but as I wrote in a 2008 article for the New York Times, I still see halos, and not the kinds with angels attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms.
My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I signed an "informed consent" saying I understood all the possible side effects, but I certainly never knew that they might last indefinitely, and that they would be more than "annoying," as my doctor promised.
But nearly three years later, they are still here. And while I could get an "enhancement" -- that's industry parlance for another surgery to correct errors -- frankly, the only thing I want near my eyes is mascara.
According to the American Society of Cataract and Refractive Surgery, most of the 13.6 million people in the United States who have had Lasik surgery since the first lasers were approved by the FDA in 1998 are pleased with the results. But others have experienced similar, if not worse, problems than I have.
Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical "adverse events."
And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who've had laser vision correction surgeries are still wearing glasses or contacts some of the time.
Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.
Still, the American Society of Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies involving 2,022 patients that specifically addressed patient satisfaction.
"Based on everything we know from the literature, and everything I know from any other elective procedure, Lasik eye surgery is the most successful elective procedure performed," said Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a co-researcher on the study.
The experience of patients like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about four years ago, seem to support this assessment. Getting the procedure, he said, was one of the best decisions he has ever made. While he does experience some starbursts, he said "it’s not bothersome at all."
But the FDA and others are taking note of what they call "quality of life" issues. In October, the FDA, the Defense Department and the National Eye Institute announced in October a three-year effort to assess adverse effects of Lasik.
The effort will involve gauging how many active-duty military patients at the Navy Refractive Surgery Center in San Diego suffered post-surgical eye problems, and a series of national, multi-center clinical trials that will study the impact on quality of life following Lasik surgery in the general population. In addition, the FDA has reopened a public docket to receive comments through Nov. 15.
"We noted that there was little consistent evaluation of the issues," said Mary Long, an FDA spokeswoman, about the reasons for why the study was initiated.
Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. "Lasik is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those few of us who speak ill of it are dismissed as cranks and/or loonies," he wrote in an e-mail message. "I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost -- human and otherwise -- of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through."
Surf the Web and you can find dozens of stories from people who have had post-Lasik difficulties: dry-eye, halos, glare. Some complications have resulted in corneal transplants. Over the last few years patient activists have bombarded the FDA with anti-Lasik e-mails, complaints and petitions.
Among them is John Hoge, 39, a businessman in Port Jefferson, N.Y., who suffered from night glare and halos and regrets not choosing the "zero risk option" of corrective lenses. A few years ago he got some experimental contact lenses that have largely taken care of the glare issue. They are expensive, he added, and are not covered by insurance.
While the FDA's recent efforts have given some patient activists a modicum of peace, many do not feel it is enough. "By not inspecting every Lasik facility in this nation, how is the FDA to know if Lasik doctors are compliant?" said Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Fla., who has experienced double vision, starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web site LifeafterLasik.com.
Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. "We screwed up," said Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health Office of Science and Technology from 1995 to 1999. "You know how some drugs have a black box warning -- it’s dangerous because of this, this and this -- we could have done something comparable to that. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials."
Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Va., agreed. "It appears that information to provide adequate informed consent was not sufficient for all prospective patients about occasions where a bad outcome could result," he said. “The present dissatisfaction rate of 5 percent is very high. Personally and professionally, I am very disappointed in the FDA."
Spokeswoman Long refutes the notion that the FDA was errant. "The FDA has reviewed safety and effectiveness information included in the manufacturer’s applications for approval," she wrote in an e-mail message. "We found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health."
Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to Lasik ambulatory facilities last May reminding them that all risks must be mentioned in every Lasik advertisement online, in print, radio or TV.
"As part of our ongoing review of Lasik and its impact on public health, we continue to look at various aspects of Lasik advertising and how we can better improve public health," said Long.
Still, an informal online search showed dozens of doctors' Web sites that do not mention risks or side effects.
As for the new study, Larry Pilot is not impressed. "The FDA is beginning to do what should have been done 10 years ago," he said. "The bottom line here is that upwards of scores of thousands of human eyes have been irreversibly damaged unnecessarily."
Dr. Solomon disagreed, maintaining that the FDA clinical trials on Lasik lasers were "rigorous" and "well-performed." "I think the FDA did an outstanding job at evaluating the technology," he said. "And the technology and procedure since approval have only gotten better."
As for me, if I had to do it all over again I wouldn't. But hindsight, alas, is 20-20.
Abby Ellin is the author of " Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help ." She lives, works, and tries to see in New York City.
Abby Ellin is the author of "Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help." Her website is AbbyEllin.com. She lives, works, and tries to see in New York City. More:
2011-02-21
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甜菊糖的陰謀，你要知
甜菊葉
圓肉、棗子、椰皇 和代糖例如 麥芽糖、甜菊糖、龍舌草蜜
關鍵時刻 20110216 可口可樂秘方+基因改造物祕辛 1/8
Raising Awareness about Electromagnetic Pollution
How your medicines are killing you
Deadly medical errors still common in U.S. hospitals
Is Gluten Bad For You?
Krishna : Myth or History Videos
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iHerb $5 Discount Off First Order
2011-02-20
How to boost your cancer preventing enzymes
5個品牌的可樂中人造焦糖色素發現明顯的 2-MI 和 4-MI 會令動物致癌
垃圾廢物處理——台灣能，香港為何不能？
137蘇州華工人受害 蘋果認廠毒物正己烷致殘
How Parents Can Ruin their Children's Health
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Ten ways public school destroys free thinking (Opinion)
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