Search Results for: avandia

FDA schedules Avandia advisory panel for July 13-14

The FDA has definitely scheduled the much-anticipated Avandia (rosiglitazone) advisory panel for July 13-14 in Gaithersburg, MD. The notification appears in the Federal Register. [Update: click here for the meeting announcement on the FDA website.] As previously speculated in the In Vivo blog, the FDA will also present a meta-analysis of trials of pioglitazone before the…

Click here to continue reading…

Up the Avandia creek without a paddle: CANOE

It’s hurricane season. By that I mean of course that the storm of controversy over Avandia will continue at least until the July FDA advisory panel and the subsequent final (?) decision by the FDA on the drug’s ultimate fate. Now, into the middle of this storm, comes CANOE, which lacks both a paddle and…

Click here to continue reading…

Handicapping the July FDA panel on Avandia

The In Vivo Blog posted a very thoughtful preview of the FDA’s upcoming advisory panel on Avandia in July. It’s even possible that they’re not exaggerating when they call it “the most important single event for FDA’s drug review in 2010 and possibly beyond.” Among other tidbits of information, the blog reveals that “Nissen recently…

Click here to continue reading…

Is time starting to run out for TIDE and Avandia?

The embattled TIDE trial, which is evaluating the cardiovascular safety of rosiglitazone (Avandia), is having trouble enrolling participants in the United States, according to a story in the Wall Street Journal by Alicia Mundy. Two sites in the US have withdrawn from the trial. One, Wake Forest University Baptist Medical Center, had been unable to recruit…

Click here to continue reading…

Vioxx, Avandia, Vytorin: absolute risk versus relative risk

There’s a fascinating discussion about Vioxx echoing around the blogosphere. (William Heisel has a nice summary here.) A few weeks ago Catherine DeAngelis, the editor of JAMA, spoke at the recent meeting of the Association of Health Care Journalists and said: I believe Vioxx should not have been taken off the market. At least a…

Click here to continue reading…

Avandia again: Nissen and JAMA editors spin RECORD round and round

Avandia is back in the news. After a month of relative silence, following the New York Times disclosure of FDA and Senate reports critical of rosiglitazone, the subsequent release of the Senate report, and the revelation that Steve Nissen had secretly recorded a meeting with GSK executives (though the significance of this last event is unclear), a…

Click here to continue reading…

Avandia: a plaque on both your houses!

Comment on the News: Avandia continues to dominate cardiovascular-related news this week. Last night the AHA and the ACC issued a highly detailed, thoughtful, though perhaps slightly over-diplomatic science advisory on TZDs and CV risk. Taking a completely opposite tack, GSK, in no mood to take prisoners, and apparently about to nominate itself for a…

Click here to continue reading…

More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review

In 2007 Steve Nissen secretly recorded a meeting with 4 GlaxoSmithKline executives, according to a story by Gardiner Harris in the New York Times. Harris reports that Nissen recently “shared the contents of the recording with The Times.”…

Click here to continue reading…

Senate releases Avandia report, GSK responds to attacks

In the wake of Friday night’s New York Times story on the Avandia controversy (see our summary here), the Senate Finance Committee has posted its 334 page report, as well as a press release and the contents of its letter to FDA Commissioner Margaret Hamburg. GlaxoSmithKline has released its own press release in which the…

Click here to continue reading…

NY Times: FDA and senate reports slam continued availability of Avandia (rosiglitazone)

A US Senate investigation concludes, along with some FDA officials, that Avandia (rosiglitazone) should no longer be on the market, according to a front page story in the New York Times by Gardiner Harris. In reports obtained by Harris, FDA officials David Graham and Kate Gelperin conclude that “rosiglitazone should be removed from the market.”  Harris says the…

Click here to continue reading…

Senate investigation revealing new details in Avandia case, WSJ reports

Senator Grassley’s investigation into the Avandia case is turning up new, potentially embarrassing details about GSK’s internal responses to the controversy, according to a story in the Wall Street Journal.  In response to the forthcoming Nissen meta-analysis, a GSK consultant wrote: “The numbers are the numbers, the analysis is very similar to our own.” The WSJ…

Click here to continue reading…

No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize

Let’s start with a quick poll:  Which is worse? A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians. B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights. If you chose B then you are…

Click here to continue reading…

Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at…

Click here to continue reading…

Rivaroxaban For ACS Gets Positive FDA Review, But Questions About ATLAS Trial Conduct Persist

The FDA will offer generally positive but also highly mixed advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee  when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing documents…

Click here to continue reading…

Vytorin: Yesterday’s News? (Guest Post)

Editor’s Note: The following guest post by Michael McCaughan originally appeared on The RPM Report, a highly valuable resource for biopharmaceutical executives on FDA, CMS and public sector issues published by Elsevier Business Intelligence. Vytorin: Yesterday’s News?  By Michael McCaughan Merck’s cholesterol drug is poised to add a unique claim to improve outcomes in as many as 19 million Americans,…

Click here to continue reading…

Industry & Medicine: It’s Complicated

Some people think industry exerts a uniformly negative force on medicine, or at least that’s the only aspect they focus on when they write or talk about the issue. Others focus exclusively on the beneficial effects of industry, and exhibit amnesia in their failure to recall the numerous instances in recent years in which the…

Click here to continue reading…

FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers…

Click here to continue reading…

FDA Announces Details of Severe New Restrictions on Rosiglitazone

The FDA has announced the details of the updated REMS (risk evaluation and mitigation strategy) for rosiglitazone, the embattled and highly controversial diabetes drug. The new REMS will sharply restrict access to and distribution of drugs containing rosiglitazone (Avandia, Avandamet, Avandaryl)….

Click here to continue reading…

Vanity Fair Article Eviscerates Globalization of Clinical Trials

The globalization of the pharmaceutical industry, and in particular the outsourcing of clinical trials to “sick Russians, homeless Poles, and slum-dwelling Chinese,” is brought to light and critically assaulted in “Deadly Medicine,” an article in Vanity Fair by Donald L. Barlett and James B. Steele. CardioBrief readers are probably familiar with this topic, but the full magnitude of…

Click here to continue reading…

News Briefs: Recurrent Stroke Prevention Guidelines, Vernakalant Trial Suspended, GSK Investigated, Generic Enoxaparin Takes Off, Kaul Speaks, Midei Sues

The American Heart Association published revised recurrent stroke prevention guidelines. The new guidelines state that recurrent stroke may be prevented by carotid angioplasty or by treating metabolic syndrome….

Click here to continue reading…

A ProPublica Investigation: Docs on Pharma Payroll Have Blemished Records, Limited Credentials

Editor’s Note: The following article is reprinted with permission from ProPublica, the “independent, non-profit newsroom that produces investigative journalism in the public interest.” This is the first installment of an ongoing investigation titled “Dollars for Doctors.” For more information and resources about the investigation, including a tool to look up drug company money paid to…

Click here to continue reading…

FDA announces safety review of pioglitazone (Actos) over cancer risk

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data is taken from a planned 5 year analysis…

Click here to continue reading…

Live-blogging the FDA Brilinta Panel-morning session

Click here for the live-blog of the afternoon session. Lunch. Back at 1 PM. 12:05: Temple summarizes the dilemma: this drug doesnt do what it’s supposed to do in the country in which it’s being asked to get approved. Kaul adds that if aspirin is the answer why isn’t this difference also reflected in the…

Click here to continue reading…

FDA finally posts briefing documents for Brilinta (ticagrelor) advisory panel

Updates: 5:30 PM: The FDA doesn’t make it easy for outsiders to wade through all the documents. A good case in point is the ticagrelor package. The main briefing document contains a summary memorandum by the Medical Team Leader, Thomas Marciniak, dated June 29. You could read the whole thing before realizing that a separate…

Click here to continue reading…

“Is it safe?”

Is it safe? Like the Nazi dentist played by Laurence Olivier in Marathon Man, we all want an answer to the question: is it safe? And like the poor victim played by Dustin Hoffman, you can torture us as much as you want but we can’t answer the question if we don’t have the data….

Click here to continue reading…