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心繫台大金山分院 留遺憾 | 冷暖人間 | 聯合新聞網
捐地蓋金山醫院的鄭玉爐,生前最大心願就是看到掛上台大醫院金山分院的招牌。金山醫院院長李龍騰昨天表示,衛生署、北縣衛生局、台大醫院已有默契要在今年10月1日揭牌,對於鄭玉爐生前無法看到金山醫院改制,他感到很遺憾。
金山鄉長許春財昨天說,鄭玉爐對台大醫院特別有感情,當初強調蓋醫院就是要讓台大醫院進來,由於法鼓山聖嚴法師力促台大醫療團隊進駐金山醫院,前兩年聖嚴還沒走時,鄭玉爐還說改制揭牌當天一定要請師父,沒想到兩人等不及,都先走了。
李龍騰說,2年前台大醫院醫療團隊進駐金山醫院後,他發現每月門診量從3500人次增加到5000人次,相信只要台大醫院接手經營,品質做好,不愁沒病人,未來金山醫院將結合復健等科別成立「溫泉觀光醫療園區」,一定可轉虧為盈。
李龍騰提到改制案迄今已拖了1年,在政府各單位間「會來會去」,上月人事行政局才核定任用員額,在等衛生署審議委員會通過,還要再申請開業執照、向法院申請點交財產等,「沒能讓鄭玉爐老先生親眼看到改制揭牌,讓人遺憾!」
總算要交接了.....
CDC Issues Updated Guidelines for Testing for Tuberculosis Infection
June 30, 2010 — The US Centers for Disease Control and Prevention (CDC) have issued updated guidelines for testing for Mycobacterium tuberculosis infection in adults and children using interferon gamma release assays (IGRAs), approved by the US Food and Drug Administration (FDA). The updated recommendations, published in the June 25 issue of Morbidity and Mortality Weekly Report, offer guidance to US public health officials, healthcare providers, and laboratory workers.
"Before 2001, the tuberculin skin test (TST) was the only practical and commercially available immunologic test for Mycobacterium tuberculosis infection approved in the United States," write Gerald H. Mazurek, MD, and colleagues from the Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC. "Recognition that interferon gamma (IFN-γ) plays a critical role in regulating cell-mediated immune responses to M. tuberculosis infection led to development of ...IGRAs for the detection of M. tuberculosis infection. IGRAs detect sensitization to M. tuberculosis by measuring IFN-γ release in response to antigens representing M. tuberculosis."
Since the CDC published 2005 guidelines for use of the QuantiFERON-TB Gold test (QFT-G), 2 new IGRAs were FDA approved to assist in diagnosing latent and active M tuberculosis infection: QuantiFERON-TB Gold In-Tube test (QFT-GIT) and the T-SPOT.TB test (T-Spot). For these assays, the antigens, methods, and interpretation criteria are different from those for previously FDA-approved IGRAs.
The updated recommendations for IGRA use were developed by a group of experts convened by the CDC to review available evidence including data submitted to FDA, published reports, and expert opinion concerning IGRAs. Studies of sensitivity, specificity, and agreement for IGRAs and tuberculin skin test yielded varying results regarding superiority of any of these tests.
"In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. tuberculosis infection," the guidelines authors write. "They may be used for surveillance purposes and to identify persons likely to benefit from treatment. Multiple additional recommendations are provided that address quality control, test selection, and medical management after testing."
Recommendations for use of IGRAs in these guidelines include the following:
- To assist in diagnosing infection with M tuberculosis, tuberculin skin tests and IGRAs may be used for surveillance or to identify persons likely to benefit from treatment (those who are or will be at increased risk for M tuberculosis infection or for progression to active tuberculosis if infected).
- Established protocols using FDA-approved test formats are required for performance and interpretation of IGRAs in compliance with Clinical Laboratory Improvement Amendment standards.
- To facilitate more refined evaluation of test results and better understanding of implications and limitations of the tests, both the standard qualitative test interpretation and the quantitative assay measurements should be reported along with the criteria used for test interpretation.
- Before blood draw, arrangements for IGRA testing should be made so that the specimen is collected in the proper tubes and so that testing can be performed within the required timeframe.
- Before implementing testing with IGRAs, each institution and tuberculosis-control program should consider availability, overall cost, potential benefits of IGRAs, and characteristics of the test population in their own setting.
- Neither the tuberculin skin test nor the IGRAs should typically be used to test persons at low risk for both infection and progression to active tuberculosis if infected, unless they are likely to be at increased risk in the future. Screening such persons is likely to cause a higher number of false-positive results and diversion of resources from higher-priority activities. When testing low-risk patients, the test with the greatest specificity should be chosen.
- The most suitable test or combination of tests to diagnose M tuberculosis infection should be chosen based on the reasons and the context for testing, test availability, and overall cost effectiveness.
- An IGRA may be used instead of a tuberculin skin test in all situations in which the CDC recommends the tuberculin skin test as an aid in diagnosing M tuberculosis infection.
- An IGRA is preferred for testing persons from groups that typically have low rates of returning to have tuberculin skin tests read and for those who have received Bacille Calmette-Guérin (BCG) as a vaccine or as cancer treatment. In the latter group, the tuberculin skin test has a higher false-positive rate.
- IGRAs or the tuberculin skin test (without preference) may be used to test recent contacts of persons with infectious tuberculosis.
- IGRAs or the tuberculin skin test (without preference) may be used for periodic screening for occupational exposure.
- For testing children younger than 5 years, the tuberculin skin test is preferred vs the IGRA. To increase diagnostic sensitivity in this age group, however, some experts recommend using an IGRA as well as the tuberculin skin test.
"Although substantial progress has been made in documenting the utility of IGRAs, additional research is needed that focuses on the value and limitations of IGRAs in situations of importance to medical care or tuberculosis control," the guidelines authors write.
MMWR Morb Mortal Wkly Rep. 2010;59(RR-5):1-28.
Clinical Context
Approximately one third of the world's population has latent tuberculosis infection, although the rate of latent tuberculosis has declined significantly during the last 30 years in the United States. The lifetime risk for active tuberculosis among patients with a history of a positive tuberculin skin test result is between 5% to 10%, although the rate of active tuberculosis has also declined in the United States in the last decade.
Identifying patients with either active or latent tuberculosis infection is a public health priority, and the introduction of IGRAs may advance this effort. IGRAs detect sensitization to M tuberculosis by measuring interferon gamma release in response to antigens presenting on M tuberculosis. The current guidelines describe the accuracy of IGRAs and offer recommendations for the use of these assays.
Study Highlights
- 4 IGRAs have been approved by the FDA for testing for tuberculosis. Assessing the accuracy of these tests is difficult because there is no "gold standard" to confirm latent tuberculosis infection or culture-negative tuberculosis.
- The sensitivity of the QFT-GIT test was 81% in detecting culture-confirmed active tuberculosis, whereas the pooled sensitivity for the T-Spot test was 91%. Both of these tests appear roughly similar to the tuberculin skin test in sensitivity to detect active tuberculosis.
- IGRAs are expected to be more specific than the tuberculin skin test because of reduced bias in interpretation and no interaction with the BCG vaccine. The pooled specificity values of QFT-GIT and T-Spot are 99% and 86%, respectively.
- Some research has suggested that IGRAs may be superior to tuberculin skin tests in diagnosing recent tuberculosis infections, whereas skin tests can be better in diagnosing remote infection. However, these studies are not unequivocal.
- IGRAs appear similar to the tuberculin skin test in predicting subsequent active tuberculosis.
- Few performance data exist for IGRA testing in children, particularly in high-risk children younger than 5 years.
- Limited data suggest that IGRAs are at least as accurate as tuberculin skin testing in detecting tuberculosis among immunocompromised persons.
- The authors recommend that IGRAs may be better than tuberculin skin tests among patients who are less likely to return for the reading of their skin tests (eg, among homeless individuals or patients who abuse drugs) and among those who previously received the BCG vaccine.
- Tuberculin skin testing is recommended vs IGRAs among children younger than 5 years.
- Either IGRAs or tuberculin skin testing may be used at the practitioners' discretion to test persons with recent contact with cases of active tuberculosis. Either test is also applicable to individuals with possible tuberculosis exposure in their workplace.
- In most cases, IGRAs and tuberculin skin tests should not be performed in the same person. Both tests may be done in high-risk cases in which the initial testing result was negative (probable false-negative) or in very low-risk cases with a positive initial test (probable false-positive).
- Neither test should generally be used among persons with a low risk for infection who are also unlikely to progress to active tuberculosis.
Clinical Implications
- The current recommendations suggest that IGRAs have a similar sensitivity but a greater specificity in diagnosing tuberculosis vs the tuberculin skin test.
- The current recommendations suggest that IGRAs are preferred vs tuberculin skin testing when the patient is less likely to return for reading of the skin test, or when the patient previously received the BCG vaccine. The tuberculin skin test remains preferred vs IGRAs among children younger than 5 years.
CME Test
Authors and Disclosures
As an organization accredited by the ACCME, Medscape, LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.
Medscape, LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.
Author(s)
Laurie Barclay, MD
Freelance writer and reviewer, Medscape, LLC
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.
Editor(s)
Brande Nicole Martin
CME Clinical Editor, Medscape, LLC
Disclosure: Brande Nicole Martin has disclosed no relevant financial relationships.
CME Author(s)
Charles P. Vega, MD
Associate Clinical Professor, Residency Program Director, Prime-LC, University of California-Irvine, Orange, California; Department of Family Medicine, University of California-Irvine, Orange, California
Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.
CME Reviewer(s)
Sarah Fleischman
CME Program Manager, Medscape, LLC
Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.
[ CLOSE WINDOW ]CME Information
CME Released: 06/30/2010; Valid for credit through 06/30/2011
Target Audience
This article is intended for primary care clinicians, infectious disease specialists, pulmonary medicine specialists, and other specialists who care for patients at risk for infection with Mycobacterium tuberculosis.
Goal
The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.
Learning Objectives
Upon completion of this activity, participants will be able to:
- Identify the accuracy of interferon gamma release assays in diagnosing tuberculosis.
- Describe how to apply interferon gamma release assays correctly in testing for tuberculosis.
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Family Physicians - maximum of 0.25 AAFP Prescribed credit(s)
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Physicians should only claim credit commensurate with the extent of their participation in the activity.
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Medscape, LLC designates this educational activity for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity. Medscape News CME has been reviewed and is acceptable for up to 300 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins September 1, 2009. Term of approval is for 1 year from this date. Each issue is approved for .25 Prescribed credits. Credit may be claimed for 1 year from the date of this issue.
Note: Total credit is subject to change based on topic selection and article length.
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Follow these steps to earn CME/CE credit*:
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最近看旅遊醫學門診時,也發現美國都是要求這種!
Safety Alerts for Human Medical Products > Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
[Posted 07/15/2010]
AUDIENCE: Cardiology, Oncology, Family Practice
ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer.
BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.
The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.
The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.
RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
[07/15/2010 - Drug Safety Communication - FDA]
-
天啊!ARB也會有事?
New Study Finds 91% of Physicians Practice Defensive Medicine
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.
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~~
Viewing 提高防治預算 抑制愛滋藥價(柯乃熒)| 蘋果日報 |
Dry lab的biostatistics的成本效益分析看來很重要阿!
Viewing 拒收Medicare醫生 創新高 | 美國新聞 | 聯合新聞網 :: Ember
美國基層醫療有問題,真稿不懂為什麼我們老是要學美國~~
臺灣近代醫療文物數位化計畫
大家可以看看精采的數位典藏計畫
Oseltamivir Efficacy Questioned in Preventing Flu Complications
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.
總算有研究懷疑Tamiflu的成效,到底這是醫學問題還是政治問題呢?




