بسم الله الرحمن الرحيم
اعزائى الاطباء فى منتديات صدفة
سلام الله عليكم ورحمته وبركاته
بداية اود ان اناشد العقول الحكيمه فى مجتمع الاطباء
اذا كان مستحضر من المستحضرات الطبيه له اثار سلبيه
واذا كان هذا المستحضر حاصل على اكثر من جواب تحزير من منظمة الاغزيه والدواء؟
واذا كانت شركة glaxosmithkline اوGSKتامرت على المرضى وعلى العالم واخفت حقيقة الاثار السلبيه خلف استخدام الافانديا
واظهرت اخر الاخبار ان الامر قد استفحل وان العقار قد تسبب فى اخر ست شهور فى وفاة اكثر من 300 مريض؟
وما زال الصمت يجرى وما زالت العقول فى غفله وغفوه
انى استنكر الغباء الطبى والتبعيه فى كل شيء فى منتهى الغباء
حيث ان زملائنا الاعزاء من الاطباء يعرفون ويفهمون ان هذا العقار المسى بالافانديا وما اشهره وما اعلمه من دواء فكل الاطباء والصيادله يعرفونه ظهرا عن قلب
ولكن هيهات
بعد ان انفضحت هذه الشركه العملاقه فى امرها
جائت الينا بعد انا هددت العام الماضى احد احد العلماء فى اكبر الجامعات الامريكيه بعد ان درس اعراض استخدام الافانديا وتسببه فى الوفاه لمريض السكر
وبعد ان اجهزت بافكارها التسويقيه على عقول العالم اخيرا قررو ليعطو حياه اطول للمستحضر بان تقوم ست مراكز بحثيه فى اوربا وثلاثه فى امريكا بدراسة الافانديا وتقييم استخدامه
وكما عرفنا وعلمنا كلنا فى معظم المحطات العالميه بانه قرر مجلس الشيوخ الامريكى بعقد جلسه ودعوى لتقييم استخدام هزا الدواء فى قرار يتجه نحو الغاؤه
وقد نشر زالك فى نيويروك تايمز لمن يرغب فى التاكد
وبعد ان افتتضح الامر قررت المراكز الطبيه البحثيه فى الغاء المشروع المزعم من قبل شركة جلاكسو لدراسة الافانديا الى اجل غير مسمى
ايها الاخوه فى منتديات كيرزى
واعنى بالاخص الاخوه الاطباء والصيادله
وكل من يعمل فى المجال الطبى
علمو مرضاكم عن هذا الدواء
استخدمو دواءا اخر بالله عليكم
حتى لا ياتى يوم يسالك الله لماز اعطيت الدواء والدواء فيه سم قاتل
وهذا بعض مما نشر فى نيويورك تايمز
Research Ties Diabetes Drug to Heart Woes
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By GARDINER HARRIS
Published: February 19, 2010
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
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J.B. Reed/Bloomberg News
Avandia was once one of the world's biggest-selling drugs.
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The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.
The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline . Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.
The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.
Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.
Hundreds of thousands still take the medicine, although some top endocrinologist s say they have sworn off the drug.
Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.’s drug center, wrote that “there are multiple conflicting opinions” about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.
“I await the recommendations of the advisory committee,” the agency’s commissioner, Dr. Margaret Hamburg, said Friday night. “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”
The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline , saying it failed to warn patients years earlier that Avandia was potentially deadly.
“Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
In response, GlaxoSmithKline said that it disagreed with the Senate investigation’s conclusions. The company said that it could not comment on internal F.D.A. documents but that “the official ruling from F.D.A. is that Avandia remain on the market.”
In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.
But Dr. Graham and Dr. Gelperin, working in the F.D.A.’s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia’s use by precisely such patients, the reports note.
“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable,” one of the reports concludes.
These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company’s patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.
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ودى اللينك
http://www.nytimes.com/2010/02/20/he...20avandia.html
04-07-2010, 03:14 PM
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