Search Results for: avandia

FDA Removes Restrictions On Avandia

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said…

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FDA Advisory Panel Backs Looser Restrictions On Avandia

After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions….

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With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial

  The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…

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FDA Schedules Another 2 Day Avandia Advisory Panel

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  “discuss the results…

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Avandia, Meridia… now it’s Aranesp’s turn before the FDA

The FDA Death Panel Cardiovascular and Renal Drugs Advisory Committee will consider the fate of darbepoetin alfa (Aranesp) on October 18. Having failed to impose the death penalty on rosiglitazone (Avandia) and Meridia (sibutramine) in recent months, it appears likely the committee will not recommend withdrawal of the drug, though in the absence of any…

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FDA keeps Avandia on market, re-adjudicates RECORD, halts TIDE; EMA suspends Avandia marketing

The FDA announced today that it would not remove rosiglitazone (Avandia) from the market but that it would impose severe new restrictions on its use. It also put on “full clinical hold” the controversial TIDE trial. The FDA is also requiring GSK to “commission an independent re-adjudication of the RECORD study.” The new REMS will require…

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2 FDA rebels criticize inclusion of Avandia defenders on July advisory panel

Two FDA officials who have been highly vocal critics of Avandia (rosiglitazone) are now suggesting that the FDA stacked the deck in favor of rosiglitazone at the July advisory committee meeting by including panel members from the earlier 2007 meeting that recommended against removing the drug from the market. In a letter published in BMJ, David…

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BMJ papers increase pressure on Avandia

A trio of papers in BMJ are turning up the heat on rosiglitazone (Avandia), prompting the editor-in-chief of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.” The detailed investigative report by BMJ features editor Deborah Cohen reviews the long and troubled history of rosiglitazone, with a focus…

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GSK letter to TIDE investigators provokes Avandia critics

A letter describing the July FDA advisory panel on Avandia that was sent by GlaxoSmithKline to TIDE investigators has sparked criticism from some FDA officials and panel members, according to an article by Gardiner Harris in the New York Times….

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FDA refers Avandia panelist conflict of interest case to HHS Inspector General

In the wake of reports earlier this week that some members of the Avandia advisory committee may have had conflicts of interest, the FDA said on Friday that it had referred the case of one panel member, David Capuzzi, to the Health and Human Services Office of Inspector General. The FDA sent CardioBrief the following…

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2 Avandia panel members found to have received money from GSK and Takeda

[This is an update of an earlier story.] At the Avandia panel last week the FDA said it had carefully reviewed disclosure statements from all potential panel members and that all 33 voting members had no relevant conflicts. But two panel members, it now turns out, had received speaking fees, one from GlaxoSmithKline and one…

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Avandia panel member received speaking fees from GSK

This post has been updated and replaced with the following story: 2 Avandia panel members found to have received money from GSK and Takeda…

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Avandia aftermath: who are the winners and losers?

Responses to the Avandia panel have been all over the map, as cleverly noted on the Wall Street Journal health blog. Avandia is “dead” (Forbes), or, perhaps worse, “now a Zombie” (BNET). By contrast, others thought the panel granted Avandia a “reprieve” (Wall Street Journal and that Avandia would now probably be allowed to stay on…

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GSK issues statement in response to FDA Avandia Panel

Here’s the statement:…

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Day 2 of the FDA Avandia Panel: Live Blogging the End

Meeting Adjourned. 4:33: Konstam: I don’t get him. He’s defended rosi for 2 days and then votes E. Now he votes against TIDE but says it should be cont’d. 4:29: Would love feedback from readers about this live-blogging experiment. This is my first time doing it. Fun but exhausting. Did you find it useful? Any…

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Day 2 of the FDA Avandia Panel- Live Blogging the Morning

NOON: LUNCH BREAK 11:59: Marciniak claims RECORD suffers from “differential informative censoring”– a great way to influence mortality statistics! 11:57: Marciniak says the problem in reporting events was NOT at the sites, it was from the middlemen. Says GSK tried to influence adjudication. 11:50: GSK clarifying concerns about RECORD.  Nearly all diabetes trials are open…

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Day 1 of the FDA Avandia Panel: Live Blogging the Afternoon

6:21: Kaul winds up to deliver a knock-out punch to the Nissen meta-analysis but Nissen pulls a judo move and turns the question around. Admitting his methodology and data are weak he asks: “who’s fault is it that there’s no better data?” After 11 years on the market GSK can only blame itself if there’s…

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Day 1 of the FDA Avandia Panel- Live Blogging the Morning

The afternoon will be blogged in a separate post. Lunch break until 1 PM. 12:05: Ungar: to answer the malfeasance question we may have to audit the entire trial 12:02: Kaul: Did Marciniak unearth malfeasance in RECORD? How many missing MIs in RECORD were biomarker-only or clinical events? 11:59: Ungar says he is concerned about…

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NY Times: GSK concealed negative Avandia study

Update: The Senate Finance Committee has released its letter to FDA leaders and documents it unearthed about the missing Avandia trials. GSK issued a response. GSK began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret, according to a report…

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Handicapping the Avandia FDA panel

Journalists, bloggers and academics are weighing in on the FDA advisory panel that begins on Tuesday. The single best thing I’ve read on the hearing is by Daniel Carpenter, a professor of government at Harvard who has a new book out about the FDA: Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Carpenter’s…

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FDA posts Avandia briefing documents ahead of next week’s advisory panel meeting

The FDA has posted the briefing documents for next week’s rosiglitazone (Avandia) advisory panel meeting. CardioBrief will be updating this page periodically with information gleaned from the documents. (See bottom of page for links to individual documents.)…

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NEJM editors were “not fully aware” of GSK and Merck manipulation of Avandia and Vytorin DSMBs

Prior to publication of key papers on rosiglitazone (Avandia) and ezetimibe (Vytorin) in the New England Journal of Medicine, the editors of the journal were not aware that trial sponsors had “manipulated” the Data and Safety Monitoring Boards (DSMBs) of the trials, according to information contained in an editorial in NEJM by its editor, Jeffrey…

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Tightening the noose yet again on Avandia

With the publication of two new papers Avandia appears to be caught again between a Nissen and a hard place.  In the first paper,  FDA official David Graham and colleagues analyze Medicare data and find an increased risk of heart failure, stroke, and death in elderly people taking rosiglitazone compared to those taking pioglitazone. In the…

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German committee recommends against reimbursement for Avandia and Actos

An influential Germany group has recommended that health insurers stop paying for Avandia (rosiglitazone, GlaxoSmithKline) and Actos (pioglitazone, Takeda). The recommendation was made by Germany’s Federal Joint Committee of doctors and health insurers. A Reuters news story quoted the committee chairman, Rainer Hess:  there are other pharmaceuticals that have no such side effects and long-term risks….

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New unpublished study may help tighten the noose around Avandia’s neck

A new unpublished study utilizing data from 227,571 Medicare patients is raising new questions about rosiglitazone (Avandia), which will be the subject of an extraordinary 2-day FDA advisory panel meeting in July. The study found that among elderly people taking a thiazolidinedione (TZD), the risk of stroke, heart failure, and death, as well as of composite…

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