Editorial: Why ARBITER 6 is important– and not important 1

Arbiter-6 is big news. CNBC will be reporting live from the convention hall on Monday when the results are released. Just in the last day or so the New York Times and the Wall Street Journal have discussed the significance– or lack of it– of the trial. On the one hand, most cardiologists I speak with don’t believe the trial is a big deal. On Wall Street, on the other hand, the feeling is very different, since analysts believe the trial might further threaten the embattled multibillion dollar Vytorin/Zetia franchise (and perhaps give a boost to Abbot’s niacin franchise).

At first glance, ARBITER-6 just isn’t important. From a purely scientific perspective ARBITER 6 doesn’t have much going for it. It’s a small trial with a surrogate endpoint. It won’t definitively answer any relevant clinical questions. So we might actually agree with the Merck PR person who asked CNBC reporter Mike Huckman: “Why are you making this such a big deal? It’s a 200-patient study.”
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26,000 patients enrolled in TIMI-50 trial of novel antiplatelet agent Reply

CardioBrief doesn’t usually cover routine announcements that companies make when trials get started or when enrollment is completed, and we’re especially busy now getting ready for the AHA, but the attached announcement from Merck about the completed patient enrollment of the TIMI 50 trial of a novel antiplatelet agent will likely be of interest to our readers. Merck (and the former Schering-Plough) have been taking plenty of beatings lately– much of them well-deserved– but that doesn’t negate the interest and excitement over SCH 530348. We used to refer to this as TRA, for “thrombin receptor antagonist,” but I guess that didn’t sound scientific and obscure enough so they’re now calling it a “antiplatelet protease activated receptor-1 (PAR-1) inhibitor.”
Click here to read the Merck press release…

Get ready for the AHA in Orlando Reply

The AHA begins this weekend in Orlando. Here are a few useful resources:

William Ganz, co-inventor of catheter and early promoter of thrombolysis, dead at 90 1

William Ganz, a Cedars-Sinai cardiologist who  helped change the entire field of cardiology more than once, died on Tuesday at the age of 90.

Ganz is perhaps best known today because of the Swann-Ganz catheter, which he co-invented in 1970 with Jeremy Swan, who was then the chief of cardiology at Cedars-Sinai. But Ganz’s more important contribution may well be the key role he played in ushering in the age of reperfusion, which transformed the role of cardiologists.
Click to continue reading, including comments from James Forrester, PK Shah, and George Diamond…

FDA sends warning letter to UCLA cardiologist Charles McKay Reply

The FDA has sent a strongly worded warning letter to UCLA cardiologist Charles McKay concerning his conduct as the principal investigator of a clinical trial. The letter was originally reported in a story  by William Heisel in Reporting on Health.

The warning letter, dated 10/23/2009, concludes that McKay “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations,” and includes many details about serious lapses in the conduct of the trial, though only 5 patients were enrolled at the site.

CardioBrief spoke briefly with McKay, who said that a “response letter has been drafted and each issue will be addressed.” McKay would not provide further details about the response, or the particular drug or company involved with the research. (The name of the drug and the company involved are redacted along with patient information in the posted version of the letter.) In 2002 McKay became the chief of cardiology at Harbor-UCLA Medical Center, though he is no longer listed as such on the center’s website. (Kenneth Narahara is now listed as the division chief. It is unclear when this change too place.)
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NEJM: Study finds risks but no benefits for renal revascularization 1

Will ASTRAL do for the renal arteries what COURAGE did for the coronary arteries? The first large, randomized trial to compare renal revascularization to medical therapy found no sign of benefit, and increased risk, for the interventional approach. The results of the ASTRAL trial are published today in the New England Journal of Medicine.
Click to continue reading, including commentary from William Boden, Christopher White, and Franz and Adrian Messerli…

JAMA studies: statins reduce gallstones, simplified lipid assessment without fasting Reply

Two lipid-related studies appearing in JAMA today will be of interest to many CardioBrief readers:

In the first study, researchers found that long term statin use (the effect didn’t kick in until after a year or a year and a half of treatment) was associated with a reduced incidence of gallstone disease and cholecystectomy. It won’t be a big surprise, since most gallstones are composed largely of cholesterol, but this is the biggest and best study yet of this important subject.

In the second study, researchers found that lipid assessment can be greatly simplified by measuring–without fasting– either total and HDL cholesterol levels or apolipoproteins.
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ARBITER-6 Family Feud: And the survey says… 3

If cardiology and medicine were as simple as Family Feud then ARBITER-6 would already be decided. (For those of you not familiar with it, Family Feud, as described by Wikipedia, is a TV game show “that pits two families against each other in a contest to name the most popular responses to a survey-type question posed to 100 people.”)

Now a Wall Street analyst is analyzing ARBITER 6 along the lines of Family Feud. According to a survey of 103 US physicians (31 cardiologists, 72 primary care physicians)  51% of the the primary care doctors and 80% of the cardiologists predicted that Niaspan would be superior to Zetia– although the validity of their opinion may be open to question since less than 35% of the physicians were even aware of ARBITER 6.
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Boston Scientific issues statement on the death of Donald Baim Reply

Here is the statement from Boston Scientific on the death of Dr. Donald Baim:

Baim BSX

It was with shock and great sadness that we learned of the death of Dr. Donald S. Baim, Boston Scientific’s Chief Medical and Scientific Officer. Dr. Baim passed away November 6 of complications of surgery for treating newly-diagnosed adrenal cancer. He was 60.

Dr. Baim served Boston Scientific with enormous dedication, distinction and effectiveness. He was the chief advocate and champion for millions of patients who were helped by our products, technologies and clinical science.
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Observational study finds increased adverse outcomes with increased usage of carotid stenting Reply

Following Medicare approval of widespread reimbursement for carotid stenting in 2005, usage of  the procedure quickly quadrupled in the Medicare population. Unfortunately, according to a new observational, retrospective study appearing in the Journal of Vascular Surgery, the increased use of carotid stents was accompanied by an increased rate of adverse events.
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Play the CME Game at home or at the AHA 6

Like everyone else who is registered for the AHA meeting that starts in less than a week, my mailbox has been overflowing for the past month of so with invitations for satellite programs taking place in Orlando. Normally I throw these out but for some reason this year I didn’t, and I watched in amazement over the weeks as the stack grew higher.

Then I remembered various anecdotes I’d heard over the years about doctors  who sit in grand rounds and compete to see who can be first to figure out the company or product sponsoring the talk. I decided to try my own version of the game. I called up an old friend, Scott Ratner, a Columbia-trained general cardiologist who’s been in private practice in Long Island for more than 20 years, and he agreed to play along.

The rules were simple. I would read the text of the invitations and he would stop me when he thought he knew who the sponsor was. Here’s what happened:
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Donald Baim, interventional cardiologist and Boston Scientific executive, dead at 60 Reply

BOSTON SCIENTIFIC DR. DONALD BAIMUpdated–CardioBrief has learned that interventional cardiologist Donald Baim, the chief medical and scientific officer of Boston Scientific, has died. Baim was 60 years old and had recently undergone surgery for adrenal cancer, according to a report by the AP.

Boston Scientific’s CEO, Ray Elliott, in a message to company employees, called Baim “a pioneer in the development of interventional cardiology,” who “served Boston Scientific with enormous dedication, distinction and effectiveness,” according to a story in heartwire.
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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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