An Embargo Becomes A Public Relations Tool 6

In general I support embargoes in medical journalism. Although the current system is far from perfect and contains all sorts of wrinkles and unexpected consequences, I support the system because it allows journalists a bit more time to work on complicated stories and to try to get them right. This week, though, I came across the single worst abuse of an embargo that I have encountered in the course of my career as a medical journalist.
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PROTECT II: Who Will Protect Us From The Protectors? 1

PROTECT II is back, but you may need to bring your own protection. Last December I wrote about a press release issued by Abiomed containing the first results of the PROTECT II trial of the company’s Impella device. [The December press release has disappeared from the Abiomed website. It is reprinted at the bottom of this article.] As I noted at the time, although companies are obligated to release the top line results of a trial if it contains material information, the detail and amount of (cherry-picked) detail contained in the press release was highly unusual. The press release struck me as an extreme example of a company seeking to spin a negative result (the trial was terminated early by the DSMB for futility) and I wondered at the time if the press release would jeopardize the presentation of the trial at a late-breaking clinical trials session.

Now it appears that the situation has evolved somewhat as predicted. I am informed by a knowledgeable source that PROTECT II “was resoundingly shot down as an ACC late-breaking clinical trial at the selection meeting for precisely the reasons” I raised last December. However, PROTECT II hasn’t entirely disappeared. It will be presented on Sunday in an i2 Special Session on Interventional Featured Clinical Studies I. My ACC source tells me that PROTECT II “was relegated to an I2 session” because of interest in the topic, “and many felt the negative result was worth promulgating.”
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Conflicts of Interest in Cardiovascular Guidelines 3

More than half of authors and reviewers of cardiovascular clinical practice guidelines have at least one conflict of interest (COI), according to a study in Archives of Internal Medicine. Todd Mendelson and colleagues analyzed the 17 most recent ACC/AHA guidelines through 2008 and found that 56% of the participants reported a COI. The most common COI was being a consultant or a member of an advisory board.

The authors concluded that “although restricting participation may prevent some qualified individuals from serving in the guidelines production process, we found that a large percentage of individuals with guidelines experience reported no disclosures, suggesting there is a substantial pool of potential
guideline writers and reviewers without COIs.”

In an accompanying commentary, Steve Nissen writes that the authors”raise disturbing questions about the independence and reliability of CPGs in cardiovascular medicine” and that “the depth and breath of industry relationships… are extraordinary.” Nissen also notes that “professional societies and their leadership are often plagued by the same commercial relationships as the CPG-writing committees.”
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Guest Post: Supermarket Chain Hawking Quaker Products & Free Cholesterol Screening Reply

Editor’s Note: The following guest post is reprinted with permission from Gary Schwitzer’s HealthNewsReview Blog.

Supermarket Chain Hawking Quaker Products & Free Cholesterol Screening

by Gary Schwitzer

An online acquaintance in public health sent me this picture with this note:

What’s next? Get your free PSA w/ 3 boxes of selenium?

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In the fine print of the campaign by Cub Foods and their pharmacies, there is no mention of the age requirement for the coupon, nor of the recommended age for cholesterol screening.
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Updated Unstable Angina/NSTEMI Guidelines Released by ACC & AHA Reply

The AHA and ACC have released a focused update of the 2007 guidelines for the management of unstable angina and NSTEMI. The guidelines incorporate new information from recent clinical trials, and deal with controversial topics such as the timing and role of invasive therapy, the choice of antiplatelet agents, and the use of platelet-function and genetic tests with antiplatelet agents.
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FDA Approves 2 New Cardiac Resynchronization Therapy-Pacemaker Systems From Medtronic Reply

The FDA has approved two new cardiac resynchronization therapy-pacemaker (CRT-P) systems manufactured by Medtronic, the company announced. Both the Consulta® and Syncra™ CRT-P systems include an ECG reporting system, which works with the company’s network data monitoring system to offer remote follow-up of heart failure patients. In addition, the Consulta includes Medtronic’s fluid monitoring system and a capture management feature that provides automatic pacing adjustment in response to physiologic changes.
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Study Finds Pioglitazone Prevents Progression To Diabetes Reply

Pioglitazone significantly reduces the development of type 2 diabetes in people with impaired glucose tolerance, according to the results of the ACT NOW study published in the New England Journal of Medicine.

Ralph DeFronzo and colleagues randomized 602 patients with impaired glucose tolerance to pioglitazone or placebo. During a median followup of  2.4 years diabetes developed in 16.7% of the placebo group versus 5% in the pioglitazone group followup (HR for pioglitazone 0.28, CI 0.16-0.49, p<0.001). The investigators calculated that 18 people needed to be treated for one year to prevent one case of diabetes. In addition to its beneficial effects on glucose metabolism, pioglitazone was associated with a decrease in diastolic blood pressure, reduced CIMT thickening, and increased HDL cholesterol. On a less positive note, pioglitazone caused a significantly larger weight gain (3.9 kg vs 0.77 kg) and more edema.

The investigators acknowledged that the effect of pioglitazone on long-term long-term diabetic complications has not been determined.

Merck Abandons Development of Factor Xa Inhibitor Betrixaban Reply

Merck announced today that it was ending development of the Factor Xa inhibitor betrixaban. The right to develop the drug will be returned to Portola Pharmaceuticals. Merck said its decision about the drug, which was poised to enter phase 3 trials, was “part of an ongoing prioritization of our late-stage pipeline.” William Lis, CEO of Portola, said that the development “represents a transformational opportunity for Portola.”
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The French Set A New Roadblock For Ticagrelor Reply

Another roadblock has popped up on what once had been thought to be a clear road to success for ticagrelor, AstraZeneca’s much discussed and anticipated antiplatelet agent. Although ticagrelor (Brilinta in the US, Brilique in France and elsewhere) received approval in Europe in December, the French health technology assessment agency, HAS (Haute Autorite de Sante) has raised questions about the risk/benefit profile of the drug. Therefore, says Bernstein pharma analyst Timothy Anderson, “the drug will not be able to advance to final pricing discussions or launch.”
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New Protocol Identifies Low Risk Chest Pain Patients Reply

Investigators in the Asia-Pacific region are proposing a “reliable, reproducible, and fast” 2-hour protocol to identify chest pain patients in the emergency department who have a low short-term risk of having a major adverse cardiac event and who may therefore be suitable for early discharge. The accelerated diagnosis protocol (ADP) consists of the TIMI score, ECG, and a point-of-care biomarker panel of troponin, creatine kinase MB, and myoglobin.
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Good News And Bad News About Physical And Sexual Activity and Cardiac Events Reply

The bad news is that physical and sexual activity can trigger acute cardiac events. The good news is that the immediate increase in risk becomes much smaller with more frequent activity, and the long term overall benefits of activity remain unchallenged. These are the key findings of a meta-analysis by Issa Dahabreh and Jessica Paulus published in JAMA of 14 case-crossover studies.
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Fibrate Prescriptions: A Tale Of Two Countries 1

Despite the absence of supporting evidence, use of fibrates in the United States more than doubled between January 2002 and December 2009. By contrast, fibrate usage remained relatively stable in Canada during the same period. In a paper published in JAMA, Cynthia Jackevicius and colleagues report on their use of IMS Health data to compare trends in the use of the drugs in the two countries. (Senior author Harlan Krumholz is the editor-in-chief of CardioExchange.)
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Study Explores Lowering the Troponin Diagnostic Threshold 1

Lowering the troponin diagnostic threshold can significantly improve outcomes after MI, claim Scottish investigators in a report published in JAMA. More than 2,000 patients with suspected ACS were studied. 64% of patients had troponin concentrations below 0.05 ng/mL, 8% had concentrations from 0.05 to 0.19 ng/mL, and 28% had concentrations 0.20 ng/mL or higher. By lowering the diagnostic threshold from 0.20 ng/mL to 0.05 ng/mL the risk of death and recurrent MI was reduced from 39% to 21% in the group with troponin concentrations from 0.05 to 0.19 ng/mL during the validation phase of the study.
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AHA Releases New Recommendations For Management Of Acute VTE Reply

The AHA is offering new guidance for the management of patients with pulmonary embolism,  iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension. The scientific statement is published online in Circulation. In addition to advice about anticoagulant therapy, the statement offers extensive recommendations about the appropriate use of fibrinolytic agents, catheter-based and surgical interventions, and IVC filters.
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Stent Company Sues Investigator Over Trial Conduct Reply

Medical device company OrbusNeich said today that it had filed a lawsuit against Pavel Cervinka, the principal investigator of a clinical trial comparing the company’s Genous stent with a bare metal stent. The trial was initially presented at the ACC in March 2009 (as reported on Heartwire here) and was subsequently published in Catheterization & Cardiovascular InterventionsThe news of the lawsuit was reported by Westby Fisher on his blog DrWes after the company issued a press release (reprinted below) about the suit.

Here is Dr. Wes’s opinion of the lawsuit:
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Lilly and Daiichi Sankyo Pull The Trigger and Kill Prasugrel Study Reply

Daiichi Sankyo and  Lilly said today that they had discontinued the TRIGGER-PCI (Testing Platelet Reactivity in Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy with Prasugrel) study  due to a lower than anticipated rate of primary endpoints (MI or cardiovascular death) in patients enrolled in the study. Taken in combination with the publication earlier this week of the negative GRAVITAS trial, the news, as noted on TCTMD, represents “another potential blow to the emerging field of personalized antiplatelet therapy.”
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Meta-Analysis of Observational Studies Finds Worse Outcomes For Rosiglitazone Compared To Pioglitazone Reply

There are no long term trials directly comparing rosiglitazone and pioglitazone. In an article published in BMJ, Yoon Kong Loke and colleagues perform a systematic review and meta-analysis of 16 observational studies with more than 800,000 thiazolidnedione users in an attempt to assess the relative cardiovascular effects of the two drugs.

When compared with pioglitazone, rosiglitazone was associated with

  • a significant increase in MI (OR 1.16, CI 1.07-1.24; P<0.001),
  • a significant increase in CHF (OR1.22, CI 1.14-1.31; P<0.001), and
  • a significant increase in death (OR 1.14, CI 1.09 to 1.20; P<0.001).

They calculated that for every 100,000 patients who received rosiglitazone rather than pioglitazone there would be 170 excess MIs, 649 excess cases of HF, and 431 excess deaths.

In an accompanying editorial Victor Montori expresses concern over the ccontinuing availability of rosiglitazone in the US, and writes that “research should be undertaken to understand what occurs when drugs are left on the market with strong warnings.” He also expresses cocnern that “regulators and prescribers do not seem to have learnt from the rosiglitazone saga,” noting that new diabetes drugs have been approved and rapidly adopted by prescribers in recent years.
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Small Study May Help Revive Hopes For Stem Cell Therapy Reply

Stem cell therapy may help reverse long-term damage after MI, according to a small, preliminary study by a group led by Joshua Hare published in Circulation: Research. 8  patients with LV dysfunction after MI received injections of autologous bone marrow progenitor cells in the LV scar and surrounding area. At one year, as assessed by cardiac MRI, there was a significant decrease in end-diastolic volume (EDV), a trend towards decreased end-systolic volume (ESV), a significant reduction in infarct size, and improved regional function in the treated infarct zone.
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ACC and MedPage Will Provide Enhanced News Coverage From 20 Cardiology Meetings Reply

As first reported here in December, Medpage Today and the ACC have announced an alliance to provide enhanced coverage of more than 20 cardiology meetings each year. The new partnership will be in place next month at the ACC annual meeting in New Orleans.

Medpage Today editorial director Peggy Peck told CardioBrief in December that the goal of the project is “to provide the most extensive coverage of cardiovascular news from meetings available on any platform.” Also in December, Medpage Today was purchased by Everyday Health, a company with a diverse portfolio of websites reaching 27 million consumers. The Medpage Today deal signals a new focus for Everyday Health, adding a professional audience to their already extensive consumer audience.
Click here to read the press release from MedPage Today…

SYNTAX Quality of Life Substudy Finds Small Benefit for CABG in Angina Relief Reply

The newest findings from the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) study finds a small benefit for CABG over PCI in relieving angina. The results of the SYNTAX quality of life substudy are published in the New England Journal of Medicine. Previous results from the SYNTAX trial, in which 1800 patients with 3-vessel or left main disease were randomized to either CABG or PCI, have generally favored CABG while leaving room for PCI in low risk patients.
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GRAVITAS Published: Who Gets To Weigh In On the Results? 3

When a major trial is published in a top clinical journal, the accompanying editorial often serves to set the agenda for discussion about the trial. With the publication in JAMA of the GRAVITAS (Gauging Responsiveness With A VerifyNow Assay– Impact on Thrombosis and Safety) trial, presented last November at the American Heart Association meeting, fresh questions are being raised about this issue, sparked by the selection of Paul Gurbel as the editorialist. Gurbel is a senior and highly-respected researcher in the field who has received large amounts of support from industry.

Here are Gurbel’s disclosures as reported in JAMA:

Dr Gurbel reported receiving research grant support from AstraZeneca, Accumetrics, Bayer, Lilly, Portola, Novartis, Pozen, sanofi-aventis, Daiichi Sankyo. Dr Gurbel also reported being a consultant or receiving honoraria from AstraZeneca, Accumetrics, Portola/ Novartis, Pozen, sanofi-aventis, Boehringer Ingleheim, Bayer, Lilly, Daiichi Sankyo, and Merck.

In a post on CardioExchange, Rick Lange and David Hillis ask the question: “Why Invite the Fox into the Henhouse?” They write:
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AHA Offers Qualified Endorsement Of Weight Loss Surgery Reply

For the first time, the AHA has offered a qualified endorsement of bariatric surgery. The scientific statement, published in Circulation, states that bariatric surgery is a relatively safe procedure that can lead to long-term weight loss and significantly improve health in appropriately selected obese patients who have been unable to lose weight nonsurgically.
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