Boston Scientific closes one case for $296 million and discloses one new subpoena 1

Boston Scientific announced today that it had agreed with the Department of Justice to plead guilty to “two misdemeanor charges related to failure to include information in reports” to the FDA and to pay $296 million to the government. The products involved in the investigation were the VENTAK PRIZM(®) 2, the CONTAK RENEWAL(®) and the CONTAK RENEWAL 2 devices, which were the subjects of product advisories in 2005, the company said.

Separately, on page 29 of a 10-Q filed with the SEC, Boston Scientific disclosed that it had received a subpoena from the HHS Inspector General “requesting certain information relating to contributions made by CRM to charities with ties to physicians or their families.” The company said it was “currently working with the government to understand the scope of the subpoena.” No further details were disclosed.
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NY Times: Why ICDs are like Maseratis and not Hondas Reply

When choosing an ICD, cardiologists have no way of knowing how one defibrillator stacks up against another,  and the cost of the defibrillators are often impossible to determine. That’s the problem explained and discussed in Barry Meier’s New York Times story, “Costs Surge for Medical Devices, but Benefits Are Opaque.”

Meier begins by telling how Medicare agreed in 2004 to vastly expand the number of patients eligible to receive ICDs by insisting that the companies agree to fund a study to determine which patients derive benefits from the devices. “Five years later, Medicare underwrites more than half of the $4 billion the nation now spends annually on defibrillators, but the agency is no closer to knowing how many lives that big investment is saving. That is because the device companies did not finance the study beyond their initial $4 million commitment, and Medicare did not pick up the slack,” writes  Meier, who in addition to defibrillators also focuses on orthopedic devices in his story.
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NEJM: On-pump CABG beats off-pump CABG at one year Reply

The first large, well-conducted trial comparing CABG with and without cardiopulmonary bypass has dispelled hope that off-pump CABG can help prevent some of the perceived disadvantages of on-pump CABG. The trial found no significant differences between the two techniques at 30 days and a significantly worse clinical outcome for off-pump at one year. The Veteran Administration’s sponsored Randomized On/Off Bypass (ROOBY) trial appears today in the New England Journal of Medicine.
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Cheerleading for science: anybody have a better idea? Reply

Last month I posted a “thought experiment” here imagining what would happen if journalists covered sports the same pom pomway they cover science (see below for the original post). Now it may not be exactly what I had in mind when I wrote the piece, but it is impossible not to be charmed and a bit turned on by the Science Cheerleader, aka Darlene Cavalier, who was an actual Philadelphia 76ers cheerleader before moving to  Discover magazine and Disney, where she began to apply her energy and intelligence to a host of worthwhile science education projects. After a decade at Disney Darlene’s started her Science Cheerleader blog, where she continues to come up with new ways to lead cheers for science.
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Massachusetts cardiologist sues Lahey Clinic after being fired, claims hospital had close ties to Medtronic 1

Interventional cardiologist David Gossman is suing his former employer, the Lahey Clinic hospitals in Burlington, Massachusetts, after he was fired for complaining about the hospital’s relationship with Medtronic. The story was reported by Thomas Burton in the Wall Street Journal Health Blog and by Molly Hamill in Courthouse News Service.
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Exenatide (Byetta) gains first line indication from FDA, but also kidney and pancreas warnings (updated) Reply

Update-November 2- The FDA today updated its web page information for exenatide and issued its own press release about the revised label for Byetta. In sharp contrast to the Lilly/Amylin press statement (below), which emphasized the new first line monotherapy indication, the FDA focused on the renal warnings:

“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.”

Later Monday afternoon Amylin and Lilly issued the following statement in response to the FDA’s update:

“The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney,” said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. “Post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems. It is also important to note that diabetes is the leading cause of kidney failure. Information about use of BYETTA in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007. We remain committed to working closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products.” (Click here to read the full statement.)

October 30- Amylin Pharmaceuticals and Eli Lilly and Company announced on Friday that Byetta (exenatide) had received an expanded indication and is now approved for first line monotherapy to help type 2 diabetics achieve glycemic control. The good news for the company was at least partially offset by a prominent placement in the new labeling that a history of pancreatitis represents an important limitation of use of the drug. The warnings and precautions section also includes a strong warning about the drug’s use in patients with renal impairment, as well as a statement that “there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.”
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Beta blockers for noncardiac surgery deemphasized in revised ACC/AHA guidelines Reply

Following the presentation of the POISE study nearly two years ago, and subsequent publication in the Lancet, clinicians have been uncertain about the precise role of beta blockers to reduce the high rate of cardiac complications surrounding noncardiac surgery. Now a focused update of guidelines from the ACC and AHA may help these clinicians.
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ARBITER-6: Wall Street chorus predicts outcome, publication, and editorials (updated) Reply

November 2 Update: CardioBrief has learned from a reliable source that ARBITER-6 and accompanying editorials will in fact be published in the New England Journal of Medicine.

October 29: Wall Street analysts, in a growing chorus, are confidently predicting that niacin will enjoy a decisive victory over ezetimibe in ARBITER 6, the much discussed trial headed by Allen Taylor that is scheduled to be presented next month at the AHA.

In addition, one analyst, Tim Anderson of Sanford Bernstein, said that he expects the trial to be published concurrently in “a major medical journal” along with– note the plural form– “some interesting editorials.”
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Halloween trick: don’t TREAT diabetes with ESAs 3

In the first adequately powered trial of an erythropoiesis-stimulating agent (ESA), darbepoetin alfa (Aranesp, Amgen) failed to reduce major clinical events and was associated with an increased risk of stroke in a population of type 2 diabetics with chronic kidney disease.

The much-anticipated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) was presented by Marc Pfeffer as a late-breaking clinical trial as part of Renal Week in San Diego, and published simultaneously in the New England Journal of Medicine. The trial randomized 4038 diabetic patients with CKD and anemia to darbepoetin alfa (target hemoglobin level of about 13 g/dl) or placebo (with rescue darbepoetin alfa when hemoglobin dropped below 9 g/dl).
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Halloween to arrive early this year with presentation of TREAT Reply

Trick or Treat? On Friday night, only hours before Halloween, the much-anticipated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) will be presented by Marc Pfeffer as a late-breaking clinical trial as part of Renal Week in San Diego. CardioBrief will have full coverage of the trial at 8:40 PM.

However, CardioBrief readers may be interested to learn that some of the major results were released by Amgen in their third-quarter conference call on October 21. Here is the relevant paragraph from the company’s press release:
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Study suggests statins may prevent flu deaths 1

People on statins are less likely to die of the flu, according to a new observational study to be presented on Friday in Philadelphia at the Annual Meeting of the Infectious Diseases Society of America.

Meredith Vandermeer (Oregon Public Health Division) and colleagues studied 2,921 patients hospitalized with lab-confirmed influenza, 26% of whom were taking statins. The researchers found that older patients and patients with cardiovascular disease had an increased risk of death, while patients on statins enjoyed a protective effect.
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UK’s NICE allows limited use of prasugrel 1

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended prasugrel (Efient) for use in the National Health Service, but only under limited conditions. Specifically, the guidance document specified that prasugrel should only be used during PCI for ACS only when emergent PCI is required for a STEMI, for stent thrombosis in patients treated with clopidogrel, or when a patient has diabetes.
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Review article highlights differences between European and North American STEMI guidelines Reply

Differences between recently published updated STEMI guidelines from the ACC/AHA and the ESC are partly the result of conflicting interpretations of the data, according to a review article in the American Heart Journal by Deepak Thomas and Robert Giugliano. Other differences may be due to the availability of new data between the publications, though on most major issues the guidelines are in accord.
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Medicare advisory committee delivers mixed review for AF catheter ablation 2

Catheter ablation for atrial fibrillation received mixed reviews from MedCAC (the Medicare Evidence Development and Coverage Advisory Committee), according to a report in the Gray Sheet. The advisory committee met on October 21 to “discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with atrial fibrillation,” according to the committee website.
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Senator queries NIH about Ballantyne and other NIH grantees who took Vytorin money 2

Following the detailed disclosure of the vast sums of money spent on academic institutions and individual physicians for Vytorin CME and consulting, Senator Grassley is now raising additional concerns about conflicts of interest involving 5 physicians who were also recipients of NIH grants.

In his letter to Francis Collins, the new NIH director, Grassley highlighted the case of Baylor’s Christie Ballantyne. The letter states that Ballantyne
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Women and MI: increasing incidence but improved survival Reply

Two new studies provide important new details about the complex situation regarding women and MI. On the one hand, middle-aged women over the last 20 years have developed an increased risk of MI. (The trend for men of the same age has been improving, by contrast, though men still have a higher absolute risk than women.) On the other hand, women who do have an MI have achieved larger larger gains in mortality than men.
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FDA advisory committee to review primary prevention indication for Crestor (rosuvastatin) Reply

On December 15 the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will evaluate AstraZeneca’s application for a primary prevention indication for rosuvastatin (Crestor). The application is based on the results of JUPITER. Click here for the FDA announcement.
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Duke cardiologist to be new president of Gladstone Institutes Reply

Roberts Sanders “Sandy” Williams will be the next president of the Gladstone Institutes, the Institutes announced yesterday. Sanders, a Duke Univeristy cardiologist, most recently served as the senior vice chancellor for academic affairs at Duke University Medical Center. Williams succeeds the Gladstone’s founding director and president, Robert Mahley, who is stepping down after 30 years, according to the announcement, “to pursue his research into the biology of apolipoprotein E in heart disease and Alzheimer’s disease.”
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Lancet: liraglutide shows considerable promise in weight loss trial 1

Can liraglutide go where rimonabant couldn’t? Can it safely and effectively help to mitigate the effects of the obesity and metabolic syndrome pandemic? Results of a new trial with liraglutide may well help restart speculation and refuel the rumor mill. But the chief limitations to liraglutide are the current absence of robust long term data and the fact that because it is a peptide it can only be given as an injection.

According to a new study from Europe appearing in the Lancet, liraglutide is more effective than both placebo and orlistat in reducing weight and improving risk factors. The startling results prompted George Bray, in an accompanying comment, to  say of liraglutide and other  GLP-1 analogs that he is “optimistic that their promise for the treatment of obesity will be fulfilled.”

Arne Astrup and colleagues reported on 564 overweight subjects who were randomized to either open-label orlistat, placebo, or one of four doses of liraglutide. At 20 weeks weight loss was significantly greater in all of the liraglutide dose groups than in the placebo or orlistat groups.

Mean weight loss (kg) % of pts w/ >5% weight loss
Liraglutide 1.2 mg 4.8 52.1
Liraglutide 1.8 mg 5.5 53.3
Liraglutide 2.4 mg 6.3 60.8
Liraglutide 3.0 mg 7.2 76.1
Orlistat 120 mg 4.1 44.2
Placebo 2,8 29.6

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FDA turns down King’s NDA for CorVue (binodenoson) Reply

The FDA has issued a completed response letter in response to King Pharmaceuticals NDA for CorVue (binodenoson). The company has not disclosed the content of the letter. Binodenoson is a pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging.

The FDA response is not entirely unexpected, as the FDA’s cardiorenal advisory panel failed to recommend the agent in July. Here are links to our earlier coverage:
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