Replies to This Discussion

Permalink Reply by Dr. L.K. Shankhdhar on September 29, 2010 at 6:19pm

I was present in Chicago when a debate was organized during ADA meet on 10th June 2007. Steven Nissen, the author of the Meta analysis had to speak against the drug, Rosiglitazone while Phyllips Home, GSK's Medical advisor had to defend the product. That happened to be the last day of the ADA meet, still some 10,000 delegates had stayed on to be in the audience. Marshals had to clear the stairs which were occupied by the delagates as seats were full. Nissen revealed that even in its initial communication with FDA, GSK had accepted that Avandia could increase risk of MI by 31%. Mystery remains why FDA still approved the drug. GSK pretended that the figure was statistically insignificant because the study was smaller and had little power of statistics. Even the future trials conducted by GSK revealed almost similar fidings again with lesser statistical power. Unquestinably conduct of GSK was fishy and FDA seemed to be a partner. Even in 2010 when the drug has been banned in Europe, FDA has occupied a peculiar postion to restrict its usage in newly diagnosed cases while there is no evidence that the risks of he drug lessen with duration of therapy. All physicians should have enough sense to stop using this drug. Ihave never used this drug since 2007.

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Permalink Reply by Brian (bsc) on September 30, 2010 at 10:06am

How can you say that. The FDA is "User Fee" supported agency. This is not illegal, this is how the business is run. They know who their customers are and it is NOT you the patient. Doctors know full well how the system works and they are the ones who must deal with the forefront of the ethical conflict on whether to provide the good of the patient as their priority.

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Permalink Reply by Brian (bsc) on September 30, 2010 at 11:37am

I don't think we disagree. The FDA cannot be trusted to act in the best interests of the patient and it will take more than an Avandia or Vioxx to change things.

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Permalink Reply by stevie on October 2, 2010 at 3:13am

Thsis relationship between the FDA and the drug industry sounds completeyl fraudulent. why was thsi allowed ro happen.surely the relationship between the FDA should come under some kind of review because it is not making decisions in the interests of the consumer. you should write to your MP(member of parliment) and point this out.

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Permalink Reply by stevie on October 2, 2010 at 3:18am

The system is tottaly corrupt. democracy in all countries is a fraud eu countries and the usa, Thats why i never vote all the MPs (members of parliment are just paid off by big business they just let us vote con us into thinking we have a say. we dont.

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Permalink Reply by Joni on October 2, 2010 at 7:26am

I have finally been taken off avandia! Yayyy! I've been "discussing" this option for about a year with my Dr. At my last appt. she was still not fully up on all the information out there about it. As far as she was concerned it was working for me, (I have lost a good amount of weight) and thought the risks were minimal for me. I am still about 40 lbs. overweight and didn't think I needed any help on the path to a stroke. I more or less insisted and she changed it. I had been taking it for almost ten years. I wonder though, has it already done damage?

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Permalink Reply by stevie on October 2, 2010 at 9:05am

hi wilson where are you from im from haringey north london
steve

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Permalink Reply by Hana Rous on October 6, 2010 at 6:04am

I now integrate my walking into my errands. Yesterday, the bank, post office, parcels office and supermarket. took me about 3 hours on foot with a stop for coffee. total distance about 4 miles. Would it have taken so much less time in the car, with ffinding places to park?
I do live in a large town, so all facilities are within about 5 miles at most and generally I can get anything I need nearer than that. Today, [now 2 pm] and I've walked several miles again.ironically I've had to take the car to the gym, because I wanted to be there by 7:30 and it takes an hour to walk there. I'm not good at getting up before 6 :o)
All it's cost me today is wet feet. I didn't use my hiking boots and I should have
I find this an excellent way tokeep fit. Doesn't take any weight off unfortunately.
Hana

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Permalink Reply by Dr. L.K. Shankhdhar on October 6, 2010 at 10:57am

I have already commented on this topic on 29th September. Still I am furnishing some more facts and figures regarding Avandia:-
• Avandia hit the market in 1999 and following a multimillion-dollar advertising campaign it quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion.
• Sales fell to $1.2 billion in 2009 (loss of 2 billion $), two years after a study was published in the New England Journal of Medicine (NEJM) that linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death compared to patients treated with other methods.
• There were many articles and reviews published about Avandia following the New England Journal of Medicine study, but research from the Mayo Clinic revealed that 90 percent of scientists who wrote favorable articles about the drug had financial ties to Glaxo.
• In 1999, drug maker SmithKline Beecham began a study to compare Avandia with another diabetes drug, Actos. The results showed that Avandia worked no better than Actos and had greater risks to the heart.
• In documents uncovered by the New York Times, the company stated they could lose $600 million from 2002 to 2004 if Avandia's heart risks were made public.
• The New York Times also obtained a sealed deposition that included testimony from Dr. Rosemary Johann-Liang, a former supervisor in the FDA's drug safety office who "left the FDA after she was disciplined for recommending that Avandia's heart warnings be strengthened."
• GlaxoSmithKline not only hid negative study data, they also manipulated study data to fit their agenda.
• "An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called "Record," found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial's tally of adverse events, mistakes that further obscured Avandia's heart risks."
• Hundreds of thousands of diabetics take Avandia every year, despite the fact that a two-year long Senate investigation released earlier this year found Avandia causes about 500 more heart attacks and 300 more cases of heart failure than Actos (Actos may also damage your heart -- just "not as much").
• The FDA also put the so-called TIDE Thiazolidinedione Intervention with Vit D Evaluation) trial – which was ordered by the FDA in 2007 to compare Avandia with Actos – on hold until they review the panel's advice. While those already enrolled in the study can continue on, fortunately no one else will be able to sign up for the dangerous study – at least for now.
• GSK completed a study in 2003 in which diabetics given Avandia suffered far more heart problems than those given a placebo.

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Permalink Reply by Billy on November 10, 2010 at 9:44am

I don't know where to start considering my on and off nature on this forum (busy busy busy) and the probability of discussions on the subject I have not seen, but do we have other people on these forums who have suffered a stroke while on Avandia? My wife had a minor one from which she recovered fairly quickly except for some movement in her left hand.

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Permalink Reply by Gail L on October 6, 2010 at 12:44pm

Thanks Manny & Tudiabetes....I live in Canada, so our drugs are always behind the US starting and being taken off the Market. So thanks for the heads up.I I'm presently on Advandia, just started taking it about 4 months ago. I have an appointment with my Dr next week, so I've emailed him the FDA articles on both Advandia & Actos, so I can discuss it with him at that time

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Permalink Reply by Terrie on October 6, 2010 at 4:43pm

Let us know how it goes Gail. My Rheumy phoned me to tell me to stop taking Vioxx the next morning after it was announced that Vioxx caused heart attacks and strokes for many Patients.

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