Abbott and AstraZeneca End Efforts to Develop Certriad (Rosuvastatin/Fenofibric Acid) Reply

Abbott and AstraZeneca announced today that they were discontinuing their collaboration for the development of Certriad, the combination of rosuvastatin and fenofibric acid. The companies received a Complete Response Letter from the FDA earlier this year, and said “the resulting regulatory delay and the commercial attractiveness of the product in the U.S. market.”
Click here to read the press release from Abbott…


Apixaban Beats Enoxaparin for Thromboprophylaxis After Hip Replacement 1

In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating both noninferiority and superiority of apixaban. The rate of major and clinically relevant nonmajor bleeding was 4.8% with apixaban and 5.0% with enoxaparin.
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Guest Post: Survey or Advertisement? 4

Editor’s Note: This following guest post by Dr. Micah Eimer is reprinted with permission from CardioExchange. Dr. Eimer is a cardiologist in the northern suburbs of Chicago.

Say Hello to Your New Drug Rep?

by Micah Eimer, MD

Most of the doctors I know have, at one time or another, responded to a web-based “survey”. While I have tried not to make a second career out of it, I will admit that I have on occasion done a survey in between patients, at lunch, or at the end of the day.  They usually take 5 to 40 minutes and ask for your opinion on the desirability of a potential new medication or about the frequency of your interaction with a particular pharmaceutical sales force.  The incentive is usually cash, anywhere from $15 to $100, depending on the time required.

Recently though, I participated in a survey on anti-platelet therapies that seemed different.  I indicated at the beginning of the survey that I had little experience with drug X.  The first part of the “survey” consisted of advertisements and studies in support of this drug (which is already on the market).  The question section asked me to rate the ads based on clarity and believability. At the end of the program, I was asked if viewing these ads would make me more likely to use drug X.
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Guest Post: Another Highly Dubious Article in the American Journal of Cardiology 1

Editor’s Note: This following guest post by Dr. Roy Poses is reprinted with permission from Health Care Renewal. In the post, Poses finds severe faults with an American Journal of Cardiology review article on beta blockers. Digging further, he finds evidence that the article may only be the tip of a much larger iceberg. You can draw your own conclusion about the validity of any comparisons with the Titanic.

Why I Shouldn’t Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

by Roy M Poses, MD

I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be getting slow this holiday season, prompted by an update email from the American Journal of Medicine, I looked at Ram CVS. Beta-blockers in hypertension. Am J Cardiol 2010: 106: 1819-1825. (Link here.)
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Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines Reply

A focused update on the guidelines for the management of atrial fibrillation has been released by the ACC, AHA, and HRS. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights of the document:
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ProPublica: Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit 1

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 a new installment in the 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 physicians, visit the Dollars for Docs website.

Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit

by Tracy Weber and Charles Ornstein ProPublica, Dec. 19, 2010, 10:04 p.m.

As medical schools wrestle with how to keep drug companies from corrupting their faculties, Stanford University is often lauded for its tough stance.

The school was one of the first to stop sales representatives from roaming its halls in 2006. It cut off the flow of free lunches and trinkets emblazoned with drug names. And last year, in a blow to its physicians’ wallets, Stanford banned them from giving paid promotional talks for pharmaceutical companies.
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CardioSource and Medpage Today Will Collaborate to Provide News Coverage of Major CV Meetings 3

Starting next month Medpage Today and ACC’s CardioSource will collaborate to offer detailed, in-depth coverage of more than 15 cardiovascular and cardiovascular-related medical meetings worldwide. The joint project, which will be called “On the Scene,” will be prominently displayed on each website and will be widely distributed via email newsletters to ACC members and cardiologists and other related healthcare specialists registered with Medpage Today. The project will be initiated in San Diego at the annual meeting of the Society of Thoracic Surgeons at the end of January.
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FDA Delays Approval of Brilinta (Ticagrelor) 1

Updated, Friday December 17, 1 PM– Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of the PLATO data, but did not request any additional studies. AstraZeneca said it is evaluating the letter and will respond to the FDA as soon as possible. The company said it remains confident that the drug will eventually gain approval.

Revising an earlier estimate based on the initial press release, a Leerink Swann analyst said on Friday that the company had “a very high degree of confidence in a rapid response to FDA’s request for add’l data analyses for the Brilinta NDA.” Seamus Fernandez said the company would respond to the FDA in January and predicted approval in 6-9 months. Although details are not yet available, a major concern of the FDA is likely to involve the lack of efficacy of ticagrelor in the pivotal PLATO trial in patients treated in the US.

Click here to read the AstraZeneca press release…

Heart Disease and Stroke in 2011: Mortality Continues to Decline, but Overall Burden Remains High 2

From 1997 to 2007, the death rate from heart disease declined 27.8% and the death rate from stroke declined 44.8%. But inpatient cardiovascular operations and procedures increased during the same period by 27%, and heart disease and stroke cost $286 billion in 2007, more than any other diagnostic group. These are some of the most striking numbers contained in the AHA’s Heart Disease and Stroke Statistics — 2011, published online in Circulation.
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False-Positive CT Angiogram Leads to Heart Transplant 4

A 52-year old woman with atypical chest pain ended up with a heart transplant after a CT angiogram to “reassure” her sparked a devastating sequence of events. Following a false-positive CT angiogram, the patient underwent coronary angiography and suffered a dissection of the left main coronary artery, followed by emergency CABG, subsequent graft failure, and multiple additional complications. The case report from the Cleveland Clinic is published online in the Archives of Internal Medicine.
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Midei’s Business As Usual Defense:”This Is the Way It’s Done” Reply

Mark Midei’s lawyer responded to the sensational reports earlier this week about his client’s relationship to Abbot. In defending his client he gave a preview of Midei’s defense. According to a story by Tricia Bishop in the Baltimore Sun, “it was business as usual for the medical profession.”

“All of these events were legal; they were done uniformly by all practitioners,” said lawyer Stephen L. Snyder, adding that “this is the way it’s done” between product sales people and doctors.

The really scary thought here is that Snyder may well be right. He may manage to exonerate his client by proving the entire medical-industrial complex guilty.

NMT Gets Plugged (Not in a Good Way) by Ben Goldacre Reply

Highly recommended weekend reading: in his Bad Science column in the UK’s Guardian, Ben Goldacre, the physician and best-selling author and columnist, brutally dissects NMT Medical, the troubled medical company that makes closure devices that have had a poor record in the clinical trial arena. CardioBrief readers will likely recall the company’s vicious assault on Peter Wilmshurst, the cardiologist who was the PI of the company’s (in)famous MIST trial until he was unceremoniously dumped by the company after he objected to the company’s dubious tactics in running the trial. When Wilmshurst told his story to TheHeart.Org (where I was then the editor) the company  sued him for libel.

Goldacre asks a simple question: since NMT has questioned the trustworthiness of Wilmshurst, just how trustworthy is NMT? And then he finds immediate evidence of the company’s untrustowrthiness right at the company’s front door, on the home page of their website:
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Spinning Out of Control: Another Look at the PROTECT II Press Release 2

Editor’s Note: This is a substantially updated version of a previously published story. It includes new commentary from David Hillis, Rick Lange, and myself.

Additional update, December 11, 2010: The PROTECT II press release appears to be a very clear violation of the Ingelfinger Rule. Although companies are obligated to release the top line results of a trial if it contains material information, the level of (cherry-picked) detail contained in the press release is highly unusual, and would appear to jeopardize publication in a major publication or presentation at a scientific meeting, especially in a late-breaking clinical trials session.

Here’s a textbook example of a bad press release (reprinted below). Or, depending on your perspective, perhaps a good example. In any case, it’s a perfect example of modern day alchemy, the ancient pseudoscience that sought to turn base substances into gold or silver.

The occasion for the press release was the early termination of the PROTECT II study. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon (IAB) in high risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring Board (DSMB), which reached a “futility determination… regarding the primary end-point,” according to the press release from the trial’s sponsor, Abiomed.
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CDC Demotes Stroke to Fourth Leading Cause of Death Reply

Chronic lower respiratory disease (CLRD) has replaced stroke as the third leading cause of death in the United States, according to preliminary 2008 statistics published by the CDC’s National Center for Health Statistics. In 2008, there were 133,750 deaths from stroke compared to 141,075 deaths from CLRD. Although the stroke rate has been declining for many years, the dramatic increase in the rate of CLRD (a 7.8% increase from 2007 to 2008) was due in large part to a revision of the cause-of-death coding practices that added many cases of pneumonia to the CLRD category. The CDC said the final 2008 mortality report will include a detailed analysis of this issue.

Here are the top 15 causes of death in the new list:
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Abbott Subsidiary Pays $41 Million Penalty for Niaspan/Advicor Kickbacks Reply

The US Department of Justice announced today that Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, will pay $41 million dollars to resolve liability for paying kickbacks and engaging in other illegal activities in marketing Advicor and Niaspan.

The Justice Department said that the company offered and paid “illegal kickbacks in the form of money, free travel, grants, honoraria and other valuable goods and services” to physicians and other medical professionals and groups. Kos also promoted the use of Advicor as a first line agent for mixed dyslipidemia, although the drug was not indicated for that purpose.

The charges include shocking details about the interaction of executives at Kos with two unnamed Louisiana cardiothoracic surgeons, who endorsed the drugs “in exchange for a series of payments.” One doctor wrote more than 4,000 prescriptions for the drugs between January 2002 and June 2006. Between 2002 and 2004 Kos “made a series of payments to the two doctors or a third party intermediary in the form of ‘sponsorship’ of continuing medical education classes conducted by the doctors and purported speakers’ fees.”
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PROTECT II Study of Impella Stopped Early for Futility Reply

This story has been substantially updated. Click here to read the updated story.

The PROTECT II study has been stopped early. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon (IAB) in high risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring Board (DSMB), which reached a “futility determination… regarding the primary end-point,” according to a press release (see below) from the trial’s sponsor, Abiomed.
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Questions Raised About Compensation and Conflicts at Duke 6

A group of Duke students protested the excessive compensation given to some top Duke officials, including cardiologist Victor Dzau, who is the Chancellor for Health Affairs at the University. In response to the protest, one noted advocate for health care reform says that Dzau has enriched himself even further through service on four separate corporate boards, and that Dzau or Duke has been less than forthcoming about fully disclosing Dzau’s board memberships.

The protesters took issue with Dzau’s total compensation for 2009 of more than $2.2 million. The figure appears excessive, especially in the context of recent financial difficulties at Duke, resulting in “frozen pay and eliminated jobs,” according to
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Meta-Analysis: Daily Aspirin Reduces Cancer Deaths 1

A new analysis finds that long-term aspirin use reduces deaths from several common cancers. Previous studies had only shown a convincing benefit in colorectal cancer. In the new meta-analysis, appearing online in the Lancet, Peter Rothwell and colleagues combined data from more than 25,000 patients enrolled in long-term randomized trials of aspirin. They showed that patients who received aspirin had a 21% reduction in cancer deaths during the trials. The beneficial effect became apparent after 5 years of follow-up.
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Senate Report on Mark Midei and Abbott: 30 Stents in 1 Day, Pig Roasts, and More 1

[Updated] Mark Midei, the interventional cardiologist who has been accused of implanting hundreds of unnecessary stents at St. Joseph Medical Center in Maryland, was congratulated by Abbott Labs for implanting 30 stents in one day. “I heard thru the grapevine that you had a truly outstanding day with Xience in the labs on Friday, perhaps setting the single day implant record,” wrote an Abbott official. Two days later, Abbott spent $2,159  for a barbecue at Midei’s house that included a whole smoked pig and other fixings.

The details of Midei’s relationship with Abbott are contained in a 170-page report from the US Senate Committee on Finance. News stories on the report appear in today’s  Baltimore Sun, New York Times, and Wall Street Journal. Click here to download a PDF of the Senate report.

Abbott provided the following statement to the Sun: “Dr. Midei has been a highly regarded physician in his field, with whom Abbott had consulted in the past. Our affiliation with Dr. Midei ended early this year.”
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Rivaroxaban Found Safe and Effective for DVT Reply

In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for rivaroxaban. The rate of major and clinically relevant non-major bleeding, the primary safety outcome, was the same in both groups.
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