Editor’s note: Here’s a great comment from a reader on the previous post about the NLA and AIM-HIGH:

I am a patient and policy prof who turned down niaspan because there was no scientific evidence of benefit relative to risk, which is not trivial.

There still isn’t, unless having more sexy numbers is considered a benefit.

The original Abbott was more clear about it: “‘I don’t know’s’ on third.”

Now we know more than we did, but apparently that is supposed not to affect how we play ball.

Someone explain to me why this isn’t crazy.

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(Updated with comments from William Boden, Sanjay Kaul, James Stein, Monty Krieger, and Allen Taylor)– The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health) trial of niacin has been stopped early by the NHLBI. The trial was designed to test the addition of high dose, extended-release niacin (Niaspan) to statins in people at risk for CV events who had well-controlled LDL but low HDL and elevated triglyceride levels.

The trial was stopped early after a regularly scheduled meeting on April 25, 2011 of the  data and safety monitoring board (DSMB) determined that there was no difference in the rate of clinical events between the two treatment groups. As expected, niacin was effective at raising HDL and lowering triglyceride levels, but it had no effect on the composite endpoint of fatal or nonfatal MI, strokes, hospitalizations for ACS, or the rate of revascularization procedures.
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The FDA has approved the Xience Nano everolimus-eluting stent, Abbott has announced. The stent is based on the same platform as the popular Xience V stent, and can be used in vessels as small as 2.25 mm. The approval was based on results from the SPIRIT Small Vessel clinical trial. The rate of target lesion failure was 8.1% in that trial, similar to the rate observed in the SPIRIT trials with XIENCE V.
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In the Women’s Health Study, which followed nearly 35,000 women for more than 15 years, mortality was significantly higher in the 1011 women who developed AF than in the women who did not, according to a report by David Conen and colleagues published in JAMA.

Here is the incidence rate (per 1000 person-years of followup) for women who developed AF compared to women without AF:
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In a study published online in Archives of Internal Medicine, John McEvoy and colleagues examine the impact of screening low risk patients with coronary CT angiography (CTA). They compared 1000 South Korean patients who underwent CTA and compared them to 1000 matched controls.

CTA identified 215 people with coronary atherosclerosis. At 90 days and at 18 months, statins and aspirin were being taken by a significantly higher percentage of patients in the CTA+ group than in the CTA- group or in the matched control group:
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The routine approval of implanted medical devices via the 510(k) premarket notification process, and in particular the controversy over Edwards’ Myxo Etlogix annuloplasty ring, get new scrutiny in an article in the Chicago Tribune by Jason Grotto and Deborah Shelton.

The Myxo controversy began in 2008 when a patient who received the device had a poor outcome after receiving the Myxo Etlogix device and discovered that the device had not undergone FDA review because, Edwards claimed,  only a pro forma notification to the FDA was required under the 510(k) process. The patient also complained that her surgeon, Patrick McCarthy of Northwestern Memorial Hospital, had not informed her that he had invented the device. (See heartwire for extensive previous coverage of the controversy.)

The Tribune article adds two important new details to the story:
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Editor’s note: The following post is reprinted with permission from ProPublica. It is the latest installment in ProPublica’s Dollars for Doctors: How Industry Money Reaches Physicians, an ongoing investigation.

Medical Schools Plug Holes in Conflict-of-Interest Policies

by Charles Ornstein and Tracy Weber ProPublica, May 19, 2011, 1:01 p.m.

Stanford University has taken disciplinary action against five faculty members at its medical school after determining they violated school policy by giving paid promotional speeches for drug companies, a spokesman said.

The move followed a ProPublica investigation in December that found Stanford [1] and other teaching hospitals weren’t enforcing their own conflict-of-interest rules.

At Stanford, which has one of the nation’s toughest policies [2], ProPublica identified more than a dozen faculty members — including medical staff leaders — who were paid speakers.
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Editor’s Note: This is the final installment of a three-part series on the National Lipid Association. The first part focused on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia, and raised questions about the role of industry in the documents. The second part explored additional questions about the NLA’s relationships with industry and other issues concerning the organization’s management. In this installment, the NLA answers questions sent to them about some of the issues raised in this series. The following material is reprinted without editing from the NLA response.
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Editor’s Note: This is the first of a three-part series on the National Lipid Association. This first part focuses on the NLA’s publication of a series of papers offering expert guidance on familial hypercholesterolemia (FH) and raises serious questions about the role of industry in the documents. The second part explores additional questions about the NLA’s relationships with industry and the management of the organization. In the third part the NLA answers questions sent to them about some of the issues raised in this series.

In conjunction with its annual meeting in New York City, the National Lipid Association (NLA) is publishing in its own Journal of Clinical Lipidology a series of clinical guidance papers authored by “expert panels” on the subject of familial hypercholesterolemia (FH). With the help of a public relations campaign, the NLA hopes to focus more attention than usual on this group of genetic lipid disorders.

Lipid experts– NLA supporters and critics alike– agree that FH is a serious disorder that can cause premature coronary artery disease and death in nearly everyone with the disease who is left untreated and that efforts should be increased to identify and treat more people with FH. But critics say that the NLA recommendations are misguided in at least one key point and, more significantly, the guidelines, and the NLA itself, are deeply tarnished by the NLA’s extensive connections with industry.
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The FDA has released the agenda, questions, roster, and briefing materials  for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee in which the ACCORD trial and the fate of Abbott’s Trilipix (fenofibric acid) will be discussed.

The key questions on which that the advisory committee members will be asked to vote are:
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Editor’s note: The following post is reprinted with permission from ProPublica. It is the latest installment in ProPublica’s Dollars for Doctors: How Industry Money Reaches Physicians, an ongoing investigation.

Cardiac Society Draws Bulk of Funding From Stent Makers

by Charles Ornstein, ProPublica, May 13, 2011, 1:27 p.m.

A Pittsburgh hospital informed 141 patients [1] earlier this year that they may have received unneeded angioplasties and stents [2], the tiny mesh tubes inserted to keep arteries open.

A Towson, Md., cardiologist faces a hearing on the fate of his medical license [3] after being accused of implanting stents unnecessarily in more than 500 patients.

And this week, a new study found [4] that more than half of patients with stable heart disease who received angioplasty and stents didn’t first receive medications, as scientific guidelines recommend.

While a host of lawsuits and research studies has raised questions about the overuse of stents, the group that represents cardiologists who implant them relies heavily on income from the makers of these devices.
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Optimal medical therapy (OMT) for patients with coronary artery disease (CAD) was not significantly boosted by the publication of the COURAGE trial, despite the clear message from that trial showing the benefits of OMT, according to a new study published in JAMA.

William Borden and colleagues used data from 467,211 patients in the National Cardiovascular Data Registry to analyze the use of OMT in CAD patients prior to PCI and at the time of discharge, both before and after COURAGE was published.
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