Morton Arnsdorf, a cardiologist at the University of Chicago Medical Center and a co-editor of UptoDate in Cardiology, died on Wednesday in a car crash. His car was struck from behind by another car driven by a 17-year-old man, according to a news report in the Post-Tribune. Police said that alcohol was “a contributing factor in the crash.” The initial impact caused Arnsdorf’s Saab to cross into opposing traffic, where it was struck by another car and burst into flames.

Arnsdorf was 69-years-old. He was a former president of the Chicago Heart Association, a trustee and member of the Steering Committee of the American Heart Association, a fellow of the Clinical Council of the American Heart Association, and the chief of the University of Chicago Section of Cardiology for nine years.

A new unpublished study utilizing data from 227,571 Medicare patients is raising new questions about rosiglitazone (Avandia), which will be the subject of an extraordinary 2-day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 endpoints including AMI or death, was higher in those taking rosiglitazone compared to those taking pioglitazone. The study was led by the FDA’s David Graham, a noted critic of Avandia and, earlier, Vioxx. Co-authors of the study are from the FDA, Acumen, and CMS.

“Given the lack of any proven, unique, and medically important health benefits of rosiglitazone compared to pioglitazone, there is no rationale for its continued availability on the market or its use by prescribing physicians or patients,” the authors conclude in the study’s manuscript.

The existence of the manuscript, and an associated brouhaha involving its possible suppression by some FDA officials, was reported by Ed Silverman on Pharmalot. Silverman reports that  Graham sent an email on May 28 to the FDA’s two top officials, Margaret Hamburg and Joshua Sharfstein, stating his situation.
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Atrial fibrillation is a big messy problem. It’s a complex disease that’s poorly understood, and as the population ages the problem will only grow larger. Although there are a variety of competing therapies to treat AF, none is completely safe and effective, and many  are quite expensive. Today’s Kaiser Health News contains a very nice overview of the problem from the perspective of several different patients, thereby providing the background and rationale for the movement for more comparative effectiveness research.  The KHN story by Julie Appleby is reprinted below, with permission from KHN. I also recommend that you read electrophysiologist Westby Fisher’s pungent and skeptical commentary on the story. Click here for previous CardioBrief coverage of AF.

Heart Problem Underscores Need to Test Competing Treatments

By Julie Appleby

KHN Staff Writer

Judy Currier remembers waking up the morning after doctors spent hours cauterizing tissue inside her heart. They were trying to correct a rapid, irregular heartbeat that had left her exhausted, frequently out of breath and at a higher risk of stroke.

“I was amazed at how quiet my heart was,” says Currier, a 69-year-old resident of Springfield,Va. But the benefits of the treatment, called catheter ablation, didn’t last. Soon her heartbeat became erratic again, forcing her to ask: What should I do?
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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 joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. It is also widely anticipated that Avandia nemesis Steve Nissen will make a presentation to the panel.

Here is the agenda as described in the Federal Register:

Agenda: On both days, the committees will focus primarily on the cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta- analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.

In the ongoing debate over industry influence in medicine, who should you believe, the critics or the defenders of industry? The answer is easy: the industry defenders. Just listen to what the defenders say when they’re talking among themselves.

For example, listen to Bill Cooney, President & CEO of Medpoint Communications, which is, in its own words, “a global leader in diversified communications services for leading pharmaceutical and biotechnology companies.” Cooney recently answered questions about virtual speaker programs in the “Ask the Experts” section of MedAdNews. Pay close attention to what he says:

MedAdNews: What is the range for return on investment for speaker Webcasts?

Cooney: First, be cautioned that several pharma and biotech companies have discontinued assessing ROI on speaker programs because they do not want to create a link between peer education activities and a “profit motive,” which they believe may trigger a legal/regulatory risk. Following that same cautious reasoning, my firm refrains from directly connecting speaker programs to ROI, although we work with some pharma and biotech companies who have assessed ROI for their virtual speaker programs….
The bottom line is that, if you can lower costs by two-thirds and maintain effectiveness, ROI is increased by 300%. And lowering the cost of speaker programs is not just good business, but it’s also good in terms of ethical marketing and public perception.

So, Cooney won’t do the math, but if you ask nicely you’ll get the answer: a 300% increase in ROI.
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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 met with FDA Commissioner Margaret Hamburg and [Principal Deputy Commissioner] Sharfstein to make the case that the TIDE trial was unethical and that Avandia needed to be withdrawn.”
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