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Medical Forum / Diseases and Disorders / Diabetes / May 2007Glaxo's Avandia Study in Jeopardy
http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070528/r euters20070528health00000010reutershealthewEDIT.xml or http://tinyurl.com/2ygd7r Glaxo's Avandia Study in Jeopardy: Official (excerpt) NEW YORK (Reuters) - Drug maker GlaxoSmithKline's medical director said the company's study of the heart risk associated with its Avandia diabetes treatment may be in jeopardy because patients have dropped out following reports of the drug's risks, The New York Times reported on Saturday. Dr. Ronald Krall told the newspaper he did not know how many of the 4,450 patients in the drug trial had withdrawn but said Glaxo diabetes was worried it may not be able to complete the trial, which is scheduled to run through 2008. Independent research committees overseeing the study, which is designed to gauge any increased risk of heart attack or stroke for people taking it, "are concerned about the ability of the study to continue" and are "considering what to do to prevent people from dropping out of the trial," the Times quoted Krall as saying. The drug, Glaxo's No. 2 seller, has been used by some 6 million people in the United States alone. > http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070528/r euters20070528health00000010reutershealthewEDIT.xml > [quoted text clipped - 25 lines] > The drug, Glaxo's No. 2 seller, has been used by some 6 million people > in the United States alone. I wonder how many, of those 6 million (those who had no previous history of heart trouble) suffered heart problems after taking Avandia. John On May 30, 1:37?am, "johnniemccoy@" <johnniemc...@NOSPAMhotmail.com> wrote: > >http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename... > [quoted text clipped - 28 lines] > I wonder how many, of those 6 million (those who had no previous history of > heart trouble) suffered heart problems after taking Avandia. Hopefully, it's not a matter of "time will tell." If I had taken Avandia for any length of time I would want to be checked out thoroughly. Kurt > http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070528/r euters20070528health00000010reutershealthewEDIT.xml > [quoted text clipped - 11 lines] > out following reports of the drug's risks, The New York Times reported > on Saturday. I don't see why they don't report interim results; they have a few years worth of data. (My suspicion is they are not because the results are bad--that the data show a higer risk of heart problems...).  SignatureJonathan Grobe >> http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070528/r euters20070528health00000010reutershealthewEDIT.xml >> [quoted text clipped - 16 lines] >the results are bad--that the data show a higer risk of heart >problems...). isn't there an ethical question when those doing the research want to try and find a way to keep people on the medication, when 1. those people do not want the med because they don't trust it and 2. because there is a question as to it's safety. People have the right to refuse anything they do not want. SignatureMâck©® Deltec CoZmore Pumper Type 1 since 1975 http://www.alt-support-diabetes.org http://www.diabetic-talk.org http://www.insulin-pumpers.org http://www.pandora.com enter "Jason & Demarco" "To announce that there must be no criticism of the President, or that we are to stand by the President right or wrong, is not only unpatriotic and servile, but is morally treasonable to the American public." ...Theodore Roosevelt (o ô) --ooO-(_)-Ooo-------------------- "I don't know half of you half as well as I should like; and I like less than half of you half as well as you deserve." ....Bilbo Baggins DISCLAIMER If you find a posting or message from me offensive, inappropriate, or disruptive, please ignore it. If you don't know how to ignore a posting, complain to me and I will be only too happy to demonstrate... . > >> http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070 > >> 528/reuters20070528health00000010reutershealthewEDIT.xml [quoted text clipped - 23 lines] > there is a question as to it's safety. People have the right to > refuse anything they do not want. Of course, and no one is denying that. >>> http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename=20070528/r euters20070528health00000010reutershealthewEDIT.xml >>> [quoted text clipped - 22 lines] >there is a question as to it's safety. People have the right to >refuse anything they do not want. A criteria that is thousands of years old is--- we use caution when taking the advice of anyone with a vested interest. Is accepted by our society that we do not allow anyone to sell a dangerous product. The definition of dangerous is set by an agency with no personal interest in the company selling a product. Since diabetes has an enlarged base of potential customers there is concern over diabetic items. We have the right to ban any product that is likely to do harm or at least examine the benefit/harm ratio. An alternative is for some people in the selling companies take responsibility or a drug they market. Then serve long jail terms if they fail. There would be few few drugs. Most individuals are unqualified and lack the resources to evaluate most drugs. > >http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename... > [quoted text clipped - 16 lines] > the results are bad--that the data show a higer risk of heart > problems...). I thought the same thing, Jonathan. Maybe they should be forced to reveal the data they have collected so far. If it were positive, then I bet they would have announced them already. Kurt > >http://diabetes.org/diabetesnewsarticle.jsp?storyId=15158739&filename... > [quoted text clipped - 16 lines] > the results are bad--that the data show a higer risk of heart > problems...). I would guess that the data is somewhat ambiguous, but with a negative trend. If it were unambiguously positive or negative, the company would reveal it either to clear the drugs name or to ward off lawsuits. Some key metrics may not have reached staistical significance. We do know that Avandia does cause fluid retention, therefore it shouldnt' be given to people with congestive heart failure, and can reduce bone density. My take at this point is that it probably does increase cardio events by some %, but we don't know the risk level for different subpopulations. All drugs will have some side-effects and the TZDs in particular are very powerful drugs with many possible actions. They do help with a1c and may preserve beta-cell function. But possibly in the future, Januvia etc, would become 2nd line therapy, replacing the TZDs. |
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