June 28, 2010 — The fear of being sued for medical malpractice is pervasive, leading 91% of physicians across all specialty lines to practice defensive medicine — ordering more tests and procedures than necessary to protect themselves from lawsuits — a new study finds.

A survey by researchers from Mount Sinai School of Medicine, New York City, also found that the same overwhelming percentage of physicians believe that tort reform measures to provide better protections against unwarranted malpractice suits are needed before any significant decrease in the ordering of unnecessary medical tests can be achieved.

Investigators questioned 2416 physicians from a variety of practice and specialty backgrounds in a survey conducted between June 25, 2009, and October 31, 2009. Their findings were published today in the June 28 issue of the Archives of Internal Medicine.

"Physicians feel they are vulnerable to malpractice lawsuits even when they practice competently within the standard of care," said Tara Bishop, MD, associate, Division of General Internal Medicine at Mount Sinai School of Medicine, and coauthor of the study, in a news release. "The study shows that an overwhelming majority of physicians support tort reform to decrease malpractice lawsuits and that unnecessary testing, a contributor to rising healthcare costs, will not decrease without it."

Physicians were asked to rate their level of agreement to 2 statements:

• "Doctors order more tests and procedures than patients need to protect themselves against malpractice suits," and
• "Unnecessary use of diagnostic tests will not decrease without protections for physicians against unwarranted malpractice suits."

There were no statistically significant differences between sex, geographic location, specialty category, or type of practice. The largest difference was that 92.6% of male physicians said they practice defensive medicine vs 86.5% of female physicians.

Although physicians in relatively low-risk specialties such as general internal medicine and pediatrics are much less likely to be sued for malpractice than obstetric/gynecologic specialists and emergency physicians, their fear is just as real, Dr. Bishop asserted in an interview with Medscape Medical News. "There's just a visceral response to the word 'malpractice,' " she said. "The entire medical community worries about being pulled into a lawsuit."

Determining the true costs of defensive medicine may be impossible because so many factors go into decisions about ordering tests, Dr. Bishop noted. Malpractice fears play a large role, but so does a desire to be thorough and careful. In a fee-for-service system that often rewards overuse, it is difficult to say how large a part defensive medicine plays in the decision to order a test.

A 2003 study by the US Department of Health and Human Services estimated the cost of defensive medicine at $60 billion a year, but the American Medical Association pegs it at $200 billion. A 2008 study by PricewaterhouseCoopers' Health Research Institute calculated the cost of defensive medicine at $210 billion per year, or 10% of all healthcare spending.

The new Mt. Sinai study coincides with several earlier surveys about how prevalent defensive medicine is. Some of the findings of those studies follow here.

• Ninety percent of physicians said they practice defensive medicine, according to a poll published in April by Jackson Healthcare, a medical staffing and information technology company. About three quarters of physicians surveyed said defensive medicine decreases patient access to healthcare and will exacerbate the growing physician shortage.
• A 2008 study by the Massachusetts Medical Society found that 83% of its physicians practice defensive medicine at a cost of at least $1.4 billion a year in that state alone. More than 20% of x-rays, computed tomography scans, magnetic resonance images, and ultrasounds; 18% of laboratory tests; 28% of specialty referrals; and 13% of hospital admissions were ordered for defensive purposes.
• A survey of 824 Pennsylvania physicians, published in 2005 in the Journal of the American Medical Association, found that 93% admit to risk-aversion tactics such as overordering tests, abandoning high-risk procedures, and avoiding the sickest of patients.

"We practice maximalist medicine to avoid missing any problem our clinical judgment tells us may be extremely remote," said Alan C. Woodward, MD, an emergency physician and past president of the Massachusetts Medical Society, to Medscape Medical News. Defensive medicine is rampant because "the threat of being sued is pervasive, and doctors simply don't trust the legal system."

In an invited commentary accompanying the Mt. Sinai study, Sen. Orrin G. Hatch (R-UT) acknowledged that consensus on Capitol Hill about tort reform "has been an elusive commodity" because of division and partisanship. "It is my hope that, as the American people see more evidence that they are paying for redundant and unuseful medical procedures, they will demand in larger numbers that real reforms be enacted to address this problem," Sen. Hatch writes. "That is what makes studies like the one by Bishop, et al., so important."

Arch Intern Med. 2010:170:1081-1084.

[CLOSE WINDOW]

Authors and Disclosures

Journalist

Mark Crane, BA

Freelance medical writer, Brick, New Jersey

Disclosure: Mark Crane has disclosed no relevant financial relationships.

防衛性醫療~~

Dry lab的biostatistics的成本效益分析看來很重要阿！

美國基層醫療有問題，真稿不懂為什麼我們老是要學美國~~

連細菌都可以人工製造了！~

努蘭醫師真的很讚！文筆這麼好得外科醫師~

大家可以看看精采的數位典藏計畫

December 9, 2009 — An updated Cochrane review has called into question the efficacy of neuraminidase inhibitors, including the most commonly used oral agent oseltamivir (Tamiflu, Roche Laboratories Inc), in preventing influenza complications in healthy adults.

The results of the review, published online December 8 in the British Medical Journal, appear with other articles on oseltamivir that all come to the same conclusion: The evidence for the drug's efficacy in reducing complications in otherwise healthy individuals with pandemic influenza is now uncertain.

According to a statement by the BMJ, the results have led to a joint investigation into oseltamivir by BMJ and Channel 4 News, based in London, United Kingdom.

Tom Jefferson, MD, from the Acute Respiratory Infections Group, Cochrane Collaboration, Rome, Italy, and colleagues updated a 2005 Cochrane review published in the Cochrane Library.

The researchers selected 20 randomized, placebo-controlled studies of neuraminidase inhibitors in otherwise healthy adults exposed to naturally occurring influenza to determine duration and incidence of symptoms, incidence of lower respiratory tract infections or their proxies, and adverse events.

They focused on oseltamivir because of the greater experience with the drug worldwide.

Few Trials Judged Adequate Also Had Shortcomings

Of the trials, only 5 were judged adequate by usual Cochrane Collaboration methods, Dr. Jefferson and colleagues write. Most of the trials were at risk for bias resulting from poor descriptions of the methods, no description of losses to follow-up, and blinding.

The authors write that their attempts to deal with these shortcomings failed. Only 3 of the 5 lead authors of the studies on oseltamivir replied to their request for more information. Of these authors, none possessed original data.

Instead, these authors referred them to Roche, oseltamivir's manufacturer. However, the company did not provide the information "as quickly as we needed it to update this review," Dr. Jefferson and colleagues write.

From their analysis, the reviewers found that oseltamivir did not reduce influenza-related lower respiratory tract complications (risk ratio, 0.55; 95% confidence interval, 0.22 - 1.35).

They also found that oseltamivir induced nausea (odds ratio, 1.79; 95% confidence interval, 1.10 - 2.93), that the evidence of rarer adverse events from pharmacovigilance studies was of poor quality, and that adverse events may have been underreported.

"Neuraminidase inhibitors have modest effectiveness against the symptoms of influenza in otherwise healthy adults. The drugs are effective postexposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective," Dr. Jefferson and colleagues conclude.

Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza.

Oseltamivir may be regarded as optional for reducing the symptoms of seasonal influenza, they add. "Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza. Independent randomized trials to resolve these uncertainties are needed."

In a related article, Peter Doshi, a doctoral student at Massachusetts Institute of Technology in Cambridge, and a coauthor of the updated Cochrane review, writes that his team of reviewers had been trying to obtain data to verify claims that oseltamivir lowers serious complications of influenza since August 2009.

Evidence Is Fragmented, Inconsistent, Contradictory

"We failed, but in failing discovered that the public evidence base for this global public health drug is fragmented, inconsistent, and contradictory. We are no longer sure that oseltamivir offers a therapeutic and public health policy advantage over cheap, over the counter drugs such as aspirin," he writes.

Mr. Doshi writes that the review team's suspicions were aroused after a Japanese pediatrician, Keiji Hayashi, MD, pointed out that their previous review, which had found that oseltamivir was effective in reducing pneumonia and other important complications of influenza, was based on a single peer-reviewed study by Kaiser and colleagues.

It turns out that the Kaiser study, which was a meta-analysis of 10 manufacturer-funded trials, included just 2 studies that were published in peer-reviewed journals. When the Cochrane reviewers tried to verify the data from the 8 unpublished trials, they found inconsistencies in the evidence for oseltamivir's effectiveness and safety.

Roche funded the Kaiser meta-analysis.

Mr. Doshi said the Kaiser paper was dropped from their new analysis. "The previous Cochrane review placed its trust in publications and included Kaiser's unpublished data, but to do so once again, despite our inability to obtain data sufficient to perform an independent analysis, would have shifted our position from that of trust in publication to that of trust in secrecy."

He also called into question US Food and Drug Administration's safety reporting rules. Manufacturers must report adverse events, but only if they occur in the United States. "In the case of oseltamivir, considering that 75% of global consumption has occurred in Japan, this has important implications for our knowledge of its safety," Mr. Doshi writes.

Treatment With Oseltamivir Unlikely to be Clinically Important

Nick Freemantle, PhD, and Melanie Calvert, MD, from the University of Birmingham, United Kingdom, were invited by BMJ to review the observational studies provided to the Cochrane reviewers by Roche. They said that in general, the studies support the conclusion that oseltamivir may reduce the incidence of complications of influenza in otherwise healthy adults, but as such events are rare, treatment with oseltamivir for most people is not likely to be clinically important.

They had several criticisms of the studies and said the studies were difficult to interpret. "Differences in baseline comorbidity or geographical distribution were present in several studies. It seems likely that some patients were included in more than one study, which undermines the ability of these studies to provide independent estimates," the authors write.

"We have remarkably few resources in this country to spend on pharmaceuticals on health and it's surprising to see such widespread use of oseltamivir. But I suppose that once you've gone and bought lots of doses then it's a bit like the situation with gun control in the US. If you have a gun in the house it's much easier to use it. But it does not mean it's the right thing to do," Dr. Freemantle said in a statement to BMJ.

Review Calls Entire Process Into Question

Fiona Godlee, MD, Editor-in-Chief of BMJ, and Mike Clarke, MD, Director of the UK Cochrane Centre, say the updated review is important because it calls into question "not only the effectiveness of oseltamivir but the whole system by which drugs are evaluated, regulated and promoted."

In her editorial, Dr. Godlee writes that the claims of the efficacy of oseltamivir, based on an analysis of 10 drug company trials, have formed a key part of decisions to stockpile the drug and made it widely available.

It was only after questions from the BMJ and Channel 4 News that Roche agreed to make full study reports available on a password-protected site, she writes.

It can't be right that the public should have to rely on this sort of detective work by academics and journalists to patch together the evidence for such a widely prescribed drug.

"It can't be right that the public should have to rely on this sort of detective work by academics and journalists to patch together the evidence for such a widely prescribed drug. Individual patient data from all trials of drugs should be readily available for scientific scrutiny," Dr. Godlee concludes.

In its reply, Roche says it has provided full responses to all questions from the BMJ and Channel 4, which "should leave no doubt about the high integrity of the data, publications, and interactions between Roche and independent investigators."

All reports were written to the standards of the regulatory authorities of Europe, the United States, and Japan, and have been accepted by all for licensing purposes. Roche has "willingly shared data and reports with numerous other eligible individuals and groups," writes James Smith, MD, International Medical Leader, Tamiflu, for Roche.

He voices concern that the Cochrane review team "chose to follow-up their inquiries through a television company rather than by approaching the manufacturer directly...it is unclear to us why Dr. Jefferson would adopt this approach, particularly given that he was a paid ad hoc consultant to Roche working on flu and oseltamivir between 1997 and 1999. During that period he worked closely with Roche experts, many of whom are still in the company, and he would therefore not have had difficulty in contacting them directly to discuss his requirements."

Dr. Smith ends by stating: "Why Dr. Jefferson and the BMJ chose to pursue their scientific enquiries through commercial television remains to be clarified."

Dr. Jefferson has reported he has received support from the UK National Institute for Health Research and the Australian National Health and Medical Research Council and that he was a paid ad hoc consultant to Roche from 1997 to 1999. Peter Doshi has reported he has no relevant financial relationships. Dr. Nick Freemantle and Dr. Melanie Calvert have reported that the BMJ helped them access 3 articles not available through their university library and that they supervise a PhD student who is supported and employed by Roche. Dr. Godlee has reported that she has published a number of articles critical of the drug industry and supports the idea that drugs should be evaluated by independent third parties rather than directly or indirectly by the drug's producers. As editor of the BMJ, she is a member of the International Committee of Medical Journal Editors and reports that the BMJ Group receives a proportion of its revenue from drug company advertising and sponsorship. Dr. Mike Clarke has reported that he is active in the Cochrane Collaboration and has a fixed-term contract with the National Institute for Health Research. Dr. Smith is international medical leader, Tamiflu, F Hofmann-La Roche.

BMJ. Published online December 8, 2009.

多元intervention和治療，都是令人振奮的事呢！

【綜合報導】衛生署日前宣布美國牛肉下月將大幅開放，引發的批評聲浪不斷升高，除綠營的兩位行政院前院長蘇貞昌、謝長廷昨都痛批政府草菅人命，連藍營台中市長胡志強也說：「馬總統先吃（美國牛肉），我就吃！」衛生署長楊志良昨雖改口表示認同談判結果，但醫界批衛生署的談判「根本是輸到脫褲」，籲全民抵制可能危害健康的美國帶骨牛肉與內臟。

爭議未息

美國過去因牛隻染狂牛症，遭各國禁止進口，人們食用感染狂牛症的牛肉，可能會在多年後出現新型庫賈氏症，多數患者一年內死亡。台美近日簽訂開放美國帶骨牛肉、牛內臟等進口我國協議。

楊：美才喪權辱國

放大圖片

陳順勝指美帶骨牛肉及牛內臟等，做成絞肉根本無法分辨來源。趙元彬攝

台中市長胡志強昨主持中市集團結婚時，被媒體詢及以後會不會吃美國牛肉，他回應：「馬總統先吃，我就吃！」他還說：「兒子在美國求學，別人吃美國牛肉他只好跟著吃，但如果從美國回台，媽媽會不會給他吃就不知道，因為這是每個為人父母不放心的地方！」不過總統府並未正面回應，僅說：「總統對食物本來就不會特別挑剔。」
胡志強表示，政府應向民眾說明為何要將開放尺度放大，「如果政府說不清楚，民眾依然有疑慮且堅決反對，就不應該開放。」
兩位行政院前院長蘇貞昌、謝長廷昨在民進黨縣市長競選造勢場合中，也痛批台灣大幅開放美國牛肉政策。蘇表示，在他行政院長任內，面對美國牛肉進口問題不是沒壓力，馬英九就任總統才一年多，就開放美國帶骨牛肉，根本罔顧民眾健康。謝長廷也痛批政府不顧民眾死活。
原對我國開放美國牛內臟表示失望的楊志良，昨則改口認同談判結果，他說談判不可能百分之百照我方意思，此次開放進口的牛產品都是世界動物組織認可，可在各國自由銷售買賣、認為安全的，對喪權辱國的說法，他不能接受。
楊志良還說，我國限制三十月齡以下的牛肉才進口，美國人自己卻吃老牛，他們吃老牛，我們吃嫩牛，還挑肥揀瘦，美國這樣才喪權辱國。

專家要求公布合約

對於開放美牛進口是否國安會主導，總統府發言人王郁琦昨以「政府是一體的」間接證實。他說，開放美國牛肉可以增進台、美之間的貿易發展關係，政府會嚴格把關。
高雄長庚醫院榮譽副院長陳順勝昨則再痛批衛生署「根本是輸到脫褲」，他更呼籲全民抵制美國帶骨牛肉與內臟，並要求衛生署公布與美方簽訂的合約細節。

衛生署長對美牛言論反覆

★10/22 內臟暫時不會進口，牛絞肉須看協商結果。
★10/23 對開放內臟表示失望，對外界要求衛生署負責，他回應：「好吧，我就下台。」
★10/24 不滿意，也只能接受，若外界仍認為開放太寬鬆，「我會知所進退。」
★10/25 對談判者高度肯定，談判不能都照自己的意思來，我當然希望內臟不要，但談判不可能百分之百照我們意思。
※資料來源：楊志良、《蘋果》資料室

下一則：國內速食業 都吃紐澳牛肉

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終於知道清朝以前簽署馬關條約時的心情~~#$$#

雙雙，一個未滿兩歲的小女孩，卻已被發現了雙眼視神經發育不全、弱視；雙耳聽障；肺動脈狹隘（先天心臟病）；輕微喉頭軟化以及發展遲緩，符合了CHARGE病徵中的其中四項症狀。由於雙雙媽媽高齡懷孕，醫生建議做羊膜穿刺，來檢查胎兒有沒有健康問題。當時診斷結果相當正常，但沒想到，雙雙在懷孕的過程中便已有基因缺陷。

想起雙雙出生的緊急時刻，雙雙媽媽還是心有餘悸，「要生產前，我被發現呼吸停止，經過緊急CPR、急救，救護車轉送奇美醫院急診，然後，插管送進加護病房，雙雙爸爸甚至簽了病危通知書。」到現在，醫生還是不清楚當時為何會爆發肺炎。這樣驚險的生產過程，雙雙媽媽又說，「短短幾天的歷程，從迎接新生命，到鬼門關前走一回，像夢一樣。」而更令她無法預料的是，一個罕病兒的到來。

有雙漂亮大眼睛的雙雙，三個月時，因為視神經發育不全的問題而無法對焦，「常常眼球朝上，在她旁邊用力地拍手，她也不會別過頭來……。」現在的她，「從一開始醫生說只知道對光有反應，到現在看她能隨手拿玩具，為了拿喜歡的電話奮力攀上箱子，爬向伸出手來大喊著『抱抱』的爸媽，雖然她與人視線相交的次數仍然極少，但我已經充滿感恩。」雙雙媽媽這麼說。

現在的雙雙，除了戴助聽器來幫助聽力之外，每周都要到醫院做復健，以及其他的早期治療。希望藉由訓練，來改善雙雙因為視覺和聽覺缺陷所引起的行動問題。然而，時常到醫院做檢查的雙雙，診療費十分的驚人，「眼睛、耳朵、心臟的問題都不是一個醫生可以解決的，也不是小診所可以做到的檢查，所以長期下來，醫療費用對我們來說，已是種負擔。」 雙雙媽媽這麼說。雖然現在雙雙還是屬於三歲以下的小孩，可以免部分負擔的費用，但三歲以後的醫療費用，仍是一大問題。

由中央健康保險局公布的重大傷病範圍，包含了呼吸器依賴患者、慢性腎衰竭需定期透析治療患者，以及經過衛生署公告之罕見疾病患者等。只要符合重大傷病範圍，都能申請重大傷病卡，並能擁有免除看病時的部分負擔費用之福利。但是「CHARGE聯合畸形」卻還沒經過政府認證，除了因為台灣醫界尚未確立病症之外，病例太少也是其中原因。

而無法領到重大傷病卡的雙雙，當要做詳細的檢查時，至少就得掛心臟科、眼科、耳鼻喉科。掛號費、檢查費，甚至是看報告，都還要再掛一次號。這樣的經濟負擔，也讓雙雙爸媽感到吃力，經濟負擔一天比一天沉重。

因此，雙雙的媽媽強烈呼籲，如果家裡的小孩，有類似CHARGE病徵的問題，希望能盡快到醫院去檢查。而現在雙雙媽媽更強調了她的目標，「找到其他的病友家庭，彼此交流打氣，甚至更進一步的，一起爭取CHARGE成為公告的罕見疾病。」

延伸閱讀：
雙雙媽媽的部落格
重大傷病範圍
重大傷病證明卡申請、換發注意事項

罕見疾病的病友和家屬都需要協助，但資源有限，真的是很大的困擾~