Senate hearings lay groundwork for assault on CME 1

On Wednesday the glaring deficiencies of CME were put on display during the Senate Special Committee on Aging hearing on “Medical Research and Education: Higher Learning or Higher Earning?” Committee Chairman Herb Kohl opened the hearing by noting that over the last decade industry funding of CME has quadrupled and now totals over $1 billion each year.

Testifying at the hearing, Steve Nissen told the committee that 50% of CME funding comes from industry. Nissen also reported that after writing several letters complaining about individual CME programs to the CME accrediting agency, ACCME, “my letters were never even acknowledged.” Nissen said “whatever the ACCME is doing it is really ineffective… we need the ACCME to go away and to replace it with something else.”
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FDA cardiorenal panel votes against binodenoson Reply

The FDA’s Cardiovascular and Renal Drugs advisory committee voted 11-5 against binodenoson (CorVue, King Pharmaceuticals), saying the data presented to them did not prove the drug was as effective as adenosine. The FDA is evaluating the NDA for binodenoson as a pharmacologic stress agent used as an adjunct to non-invasive myocardial perfusion imaging (MPI) tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease (CAD).
Click to continue reading, including a detailed comment from panel member Sanjay Kaul…

Senate committee to hold hearings on CME Reply

The Senate Special Committee on Aging will hold a hearing on “Medical Research and Education: Higher Learning or Higher Earning?” on Wednesday afternoon. CardioBrief has learned that one major focus of the hearing will be CME, and that Steve Nissen will be testifying. The hearing will be webcast at 2 PM ET. Click here to view the webcast.

Partly in response to the Senate hearing, we are also now publicly disclosing an initial, skeletal version of a proposal regarding CME. We hope to release a more complete version of the proposal in the near future. In brief, the proposal is a recommendation for the NIH to start a CME.Gov website along the lines of the ClinicalTrials.Gov website. The site would serve as a central repository for all significant information for CME programs. It would require all CME supporters, producers, and participants to fully disclose all funding information. No CME credit could be granted unless all the required information about the CME program were first registered on the website. We hope to have much more to say about this topic in the near future.
Click to read a press release from Senator Kohl…

DES usage plunged immediately following warnings at ESC 2006 Reply

Following the presentation at ESC 2006 in Stockholm of studies questioning the safety of drug-eluting stents (DES), usage of DES in NSTEMI patients plunged almost immediately from 90% to below 60%, according to a new report in Circulation: Cardiovascular Quality and Outcomes based on data from the CRUSADE and ACTION-GWTG registries.

“We were interested in whether practice patterns changed after the presentation of these studies,” said Matthew Roe, lead author of the study, in an AHA press release. “That’s indeed what we showed.”

“There was a rapid change of practice patterns” after the ESC presentations,” he said. “To our knowledge, this was the most rapid change in practice patterns in cardiology. We presume it was because of a rapid uptake of information.”

In their paper the authors elaborate on this important point:

…the rapid decline in DES use after the ESC 2006 meeting contrasts with the relative lack of impact of previous clinical alerts and public health recommendations in cardiovascular medicine, thus indicating that the rapid dissemination of information through various media and scientific outlets may become the predominant stimulus for changes in practice in the future.

Click here to read the AHA press release…

Dronedarone (Multaq) to cost $9/day 2

Dronedarone (Multaq) is now available in US pharmacies at a typical retail cost of $9 per day ($4.50 per pill). The drug’s price is significantly higher than earlier Wall Street estimates, according to news stories on Dow Jones and Reuters. Wall Street analysts are now raising their estimates of the drug’s anticipated revenue.
Click for links to previous coverage of dronedarone and a press release from Sanofi-aventis…

FDA review raises questions about expanded indication for telmisartan 1

FDA reviewers have raised a number of serious issues about the telmisartan application for an expanded indication. Telmisartan is now approved for the treatment of hypertension. The FDA Cardiovascular and Renal Drugs Advisory Committee will meet on Wednesday to evaluate the proposed indication for telmisartan to reduce risk of myocardial infarction (MI), stroke, cardiovascular (CV) deaths or hospitalization for congestive heart failure (CHF) in patients 55 years or older at high risk of developing major CV events. The expanded indication is based on data from one pivotal clinical trial, ONTARGET, and two supportive trials, TRANSCEND and PRoFESS.

The FDA reviewers raised questions about both the efficacy and safety of telmisartan. At the core of the efficacy review is the complex issue of whether telmisartan (an angiotensin-receptor blocker) is non-inferior to ramipril (an ACE inhibitor). The FDA reviewers write that the non-inferiority margin proposed by the sponsor (1.13) “seems too liberal.” It seems likely that a large part of the panel discussion on Wednesday afternoon will revolve around the definition and clinical significance of non-inferiority.
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FDA briefing documents: binodenoson in for some tough questions 1

The FDA has posted briefing materials for the July 29 meeting of the Cardiovascular and Renal Drugs advisory committee to assess the NDA for binodenoson (CorVue, King Pharmaceuticals) as a pharmacologic stress agent used as an adjunct to non-invasive myocardial perfusion imaging (MPI) tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease (CAD).

To gain approval it appears that King Pharmaceuticals will have to answer accusations by the FDA that the company moved the goalposts in the middle of the game by changing the primary endpoints of the trial without the concurrence of the FDA:
Click to continue reading, including links to the FDA documents…

FDA panel recommends approval of Medtronic’s Melody transcatheter pulmonary valve 1

The FDA’s Circulatory System Devices panel voted unanimously to approve the humanitarian device exemption for Medtronic’s Melody transcatheter pulmonary valve.

A Reuters news story quoted panel member William Maisel, who said “there is room for improvement for the device” but the company “demonstrated safety and probable benefit.”
Click to continue reading, including a press release from Medtronic…

Cardiology strikes back: Bove, Lewin, Weber & Black defend ties to industry 1

In the wake of numerous congressional investigations,  an influential report on conflict of interest from the IOM, a JAMA special communication by Rothman et al advocating that medical groups sever most of their ties to industry, and many other calls for wholesale reform, several groups of influential and powerful physicians are striking back and defending academic ties to industry.

The most visible example of this reaction against reform will take place tomorrow when the first meeting of the Association of Clinical Researchers and Educators (ACRE) will take place at Brigham & Women’s Hospital in Boston. ACRE, in its own words, is
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Shocking studies in JAMA show benefits of healthy lifestyles Reply

Findings from two large new studies from the Nurses Health Study and the Physicians Health Study should surprise no one except investors in tobacco and fast food companies.

A report from the Nurse’s Health Study found that hypertension could be significantly reduced by adherence to modifiable lifestyle and dietary factors including maintaining normal weight, daily vigorous exercise, eating a diet high in fruits, vegetables, low-fat dairy products and low in sodium and taking a folic acid supplement.

A report from the Physicians Health Study found that heart failure was significantly reduced in men who exercised regularly, drank moderately, did not smoke, who were not overweight and had a diet that included cereal and fruits and vegetables.
Click to continue reading, including press releases from JAMA and a press statement from the ESC…

FDA posts briefing documents on Medtronic transcatheter pulmonary valve Reply

The FDA has posted its briefing documents for Wednesday’s meeting of the Circulatory System Devices Panel advisory committee meeting to assess the HDE application for Medtronic’s Melody transcatheter pulmonary valve and delivery system. The briefing documents say that the device met its primary efficacy and safety endpoints, but go on to raise questions about the risk of stent fractures.

Here are links to all the briefing material:
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2 studies show benefits of lowering salt 2

High-salt diets contribute to resistant hypertension, and modest reductions in salt can help reduce blood pressure in black, Asian, and white populations, according to two new studies published today in Hypertension.

In the first study, a randomized, cross-over study of a high-salt versus a low-salt diet in 12 patients with resistant hypertension, systolic blood pressure decreased 22.7 mm Hg and diastolic blood pressure decreased 9.1 mm Hg on the low-salt diet.
Click here to continue, including press releases from the American Heart Association and a comment from the president of the Salt Institute…

COURAGE fortified by angiography study and Califf editorial Reply

No study in recent years has provoked as much intense reaction– both positive and negative– as COURAGE. In particular, critics from the interventional community have argued that the results did not apply to a large percentage of their patients. Now a new analysis of angiographic data from COURAGE, published in Circulation: Cardiovascular Quality and Outcomes, provides important evidence that the findings of COURAGE should be widely applicable.
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Prasugrel priced 18% more than clopidogrel in US by Lilly/Daiichi Sankyo 1

Effient (prasugrel) will cost 18% more than Plavix (clopidogrel) in the US, according to a Dow Jones newswire story yesterday by Peter Loftus.

The cost for Effient will be $5.45 per pill, compared to $4.60 for Plavix. Loftus spoke with Javan Collins, vice president of Lilly’s U.S. cardiovascular business, who also said that the drug would become available in the middle of August.
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NEJM: Bhatt editorial evaluates prasugrel in clinical practice 2

Only days after the FDA approval of prasugrel, the New England Journal of Medicine has published an editorial by Deepak Bhatt on “Prasugrel in Clinical Practice.

Bhatt writes that because prasugrel is a more potent inhibitor of the platelet receptor than previously available theinopyridines it can cause “a greater reduction in ischemic events– but it may also lead to more bleeding.” Bhatt notes that TRITON-TIMI 38 demonstrated both increased efficacy and bleeding, and warns that “the risk of bleeding might be increased still further with real-life use, and the FDA has required that prasugrel’s labeling include a black-box warning about that risk.”
Click to continue reading, including commentary from Bob Harrington, David Kandzari, Sanjay Kaul, and Victor Serebruany…

Approval aftermath: now the real prasugrel battle begins 2

Following last Friday’s much anticipated approval of prasugrel, the consensus among observers and analysts is that there is no consensus about the ultimate fate of prasugrel. Given the boxed warning and limited indication, prasugrel will have a hard time capturing the enormous market currently dominated by clopidogrel. Following clopidogrel’s patent expiration prasugrel will then have to prove its cost effectiveness. But Lilly and Daiichi Sankyo are certain to work hard to build a substantial market for their drug.
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Teenage girl thriving after late donor cardiectomy 10 years after heterotopic transplant Reply

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In 1994, at the age of two years, Hannah Clark, suffering from severe heart failure, underwent a heterotopic cardiac transplantation. More than ten years later the donor heart was removed, following many episodes of post-transplant lymphoproliferative disorder and recovery of her native heart. Now, more than 3 years after the second operation, Hannah’s remarkable story has been published in the Lancet and she has appeared in public at a news conference in London along with her surgeon, Sir Magdi Yacoub.
Click here to read the Lancet press release…

Study estimates cancer risks for widespread calcium screening 1

Calcium artery calcium (CAC) screening might cause 42 and 62 excess cases of cancer per 100,000 men and women respectively, according to a new study in the Archives of Internal Medicine. The study by Kim and colleagues also found a more than 10-fold variation in radiation dose.

The investigators note that the potential impact of even small increases in risk could have significant public health implications. SHAPE, for instance, advocates CAC screening for about 50 million Americans.
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Lock and Load: ACC takes aim at proposed CMS cuts to cardiologists 1

The ACC has gone into full battle mode to fight proposed CMS cuts to reimbursement for cardiology services.

ACC CEO Jack Lewin writes in his blog: “We have been rocked by this proposal and now it’s time to roll!” But the ACC appears to be more in a mood to “lock and load”  than “rock ‘n roll.” According to a special edition of the ACC Advocate newsletter, the CMS proposal could results in cuts of 30% or more for many cardiology practices.

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