Today's Avandia Hearing at the FDA
If you want to follow the blow-by-blow of today's FDA hearing on the marketing restrictions on Avandia (rosiglitazone), I can send you to Matthew Herper's Twitter feed. He has the goods. (Source: In the Pipeline)
Source: In the Pipeline - June 6, 2013 Category: Chemists Tags: Regulatory Affairs Source Type: blogs
Dr Sidney Wolfe retires with a bang!
Avandia: A Drug That Should Be BannedStatement of Sidney M. Wolfe MD, Founder and Senior Adviser, Public Citizen’s Health Research GroupJune 6, 2013Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779Note: Dr. Sidney Wolfe is testifying today before two FDA advisory committees that are meeting to consider a range of actions on the dangerous diabetes drug Avandia (rosiglitazone), from lifting restrictions to banning it. Dr. Wolfe’s testimony is available at http://www.citizen.org/hrg2134.According to U.S. Food and Drug Administration-acquired marketing data, since late 2010, when the diabetes drug Ava...
Source: PharmaGossip - June 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
AVANDIA READER POLL: Is FDA Correct To Hold This Meeting?
As the controversial FDA advisory committee meeting gets under way this morning (watch here), a key question remains – would easing restrictions on the troubled Avandia diabetes pill really matter? The GlaxoSmithKline drug, which was linked to heart attacks and strokes, is effectively under lock and key, thanks to a REMS program put in place in 2010 following a contentious FDA meeting that same year.
The meeting is being held to review a Glaxo clinical trial called RECORD, which purported to refute a 2007 meta-analysis that found much greater cardiovascular risks than were previously known. That prompted a US Senate prob...
Source: Pharmalot - June 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? Another shiny day is unfolding over the Pharmalot corporate campus, where the birds are chirping, the dogs are barking, the cicadas are buzzing and the short people are hustling about. As for us, we are keeping tabs on the interesting FDA meeting concerning the Avandia diabetes pill and will keep you posted on any twists and turns. Meanwhile, here are some tidbits to get you started. Hope your day goes well and drop us a line if you hear anything fascinating...
Japan Allows Online Sales Of Nearly All OTC Drugs (Japan Times)
Fluoroquinolone Antibiotics Linked To Kidney Damage I...
Source: Pharmalot - June 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Avandia, An FDA War Of Words And 'Unprofessional Language'
The enmity between Tom Marciniak, an FDA medical reviewer, and his supervisors at the agency, is on full display in a remarkable set of memos that the agency has filed in preparation for the controversial two-day meeting that starts tomorrow to reassess the Avandia diabetes pill.
At issue is whether restrictions should be lifted for the GlaxoSmithKline drug, which was linked to heart attacks and strokes amid controversy over undisclosed clinical trial data several years ago. And central to the discussion is a re-adjudication of a Glaxo (GSK) study called RECORD. And how does the FDA generally regard the re-adjudication? Mo...
Source: Pharmalot - June 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
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 by the Duke Clinical Research Institute (DCRI) confirmed the initial finding of the trial that rosiglitazone was not associated with an increased risk for cardiovascular events. For the most part, the FDA documents released today ...
Source: CardioBrief - June 3, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Avandia Clinical research diabetes FDA food and drug administration GlaxoSmithKline Rosiglitazone steve nissen Source Type: blogs
Glaxo's Stewart On Avandia Meeting: 'There's A Logical Conclusion'
A controversial FDA advisory committee meeting will take place this week to determine whether restrictions on the Avandia diabetes pill should be removed, continued, modified or withdrawn altogether. The move comes nearly three years after the agency held an earlier meeting to review evidence that the GlaxoSmithKline drug was linked to heart attacks and strokes, following a ruckus over the extent to which the data was properly disclosed. A 2007 meta-analysis published in The New England Journal of Medicine found greater-than-expected cardiovascular risks, while a Glaxo trial called RECORD did not. Despite issuing restricti...
Source: Pharmalot - June 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Medicare Advantage Plans Reviewing Options for Pharmaceutical Lawsuits
In a related case reported in mid-April of this year, Bloomberg News reported that the U.S. Supreme Court left intact a ruling that lets insurers including UnitedHealth Group Inc. and Humana Inc. sue GlaxoSmithKline (GSK) to recoup benefits they pay under the Medicare Advantage program, which covers approximately 13 million people.
This is another example for drug and device manufacturers of the subsequent and parallel civil and state liability companies face after settling with the federal government and federal health agencies.
Specifically, the Supreme Court rejected an appeal by GSK, which argued unsuccess...
Source: Policy and Medicine - June 3, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers
Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk of cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug safety. In the past he has raised questions about other major drugs, including prasugrel, rosiglitazone, and rivaroxaban. But Marciniak’s boss, Ellis Unger, who is the acting director of the office of new drugs, told the WSJ that Marciniak’s conc...
Source: CardioBrief - May 31, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes Angiotensin II receptor antagonist FDA food and drug administration Marciniak Wall Street Journal Source Type: blogs
A Lone Voice Raises Alarms on Lucrative Diabetes Drugs - NYT
LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.“I said, I’m not interested in your money, go away,” Dr. Butler recalled.Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9...
Source: PharmaGossip - May 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Controversial Analysis Of Disputed Trial Finds Avandia Is Safe, After All
File this under ‘what a surprise!’ Next month, the FDA will hold a two-day meeting to discuss a reassessment of a hotly contested clinical trial that was the focus of a contentious 2010 FDA panel meeting held to review the controversial Avandia diabetes pill (back story).
And now, the results are out. The re-adjudication of the RECORD trial shows the drug was not associated with a significantly increased risk of cardiovascular events and the outcomes were consistent with the original analysis of the GlaxoSmithKline (GSK) pill.
Although the FDA restricted Avandia use to only Type 2 diabetes who are unable to benefit fro...
Source: Pharmalot - May 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next week on June 5 and 6. GlaxoSmithKline posted a summary of the results (PDF) on its website last October, but its presence was not generally known until the publication of an article in BioCentury on Tuesday. … The FDA also required GSK to commission the More&#...
Source: CardioBrief - May 29, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Avandia FDA food and drug administration GlaxoSmithKline GSK Nissen Rosiglitazone Source Type: blogs
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 least one source of fierce criticism won’t be participating in the panel. Steve Nissen, who originally raised concerns about the drug and who has remained the most consistent critic of the drug, will not participate in the deliberations or present to More… (Source: CardioBrief)
Source: CardioBrief - May 24, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes American College of Cardiology Avandia FDA food and drug administration GlaxoSmithKline Nissen Rosiglitazone Source Type: blogs
States Becoming More Aggressive Prosecuting Off Label Promotion
For the last several years, we have reported extensively about the government settlements, investigations, and prosecutions of pharmaceutical and medical device companies for various fraud and abuse, FCPA and FDA violations. Almost all of these cases has resulted in multi-billion dollar settlements, corporate integrity agreements and various other legal, regulatory and compliance obligations.
Consequently, a growing concern and trend that companies are now facing are separate and parallel civil and criminal enforcement actions at the state level for the same or similar conduct companies settled with the federal go...
Source: Policy and Medicine - May 24, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Steve Nissen: The FDA Meeting On Avandia Will Be A 'Whitewash'
Next month, the FDA will hold a two-day meeting to discuss the results of a clinical trial for the Avandia diabetes pill, three years after the agency greatly restricted use of the controversial drug. And Steve Nissen, who co-authored a meta-analysis that several years ago found increased cardiovascular risks with the GlaxoSmithKline pill, believes the FDA has a hidden agenda for convening the session.
“The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research, is seeking to avoid accountability for its role in the Avandia tragedy,...
Source: Pharmalot - May 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
