Mixed Results For ApoA-1 Therapies

–It’s still not time to write the obituary for all HDL therapies. There was good news and bad news for a category of experimental drugs that attempt to mimic the putative beneficial effect of HDL at the American Heart Association meeting in New Orleans. Thirteen years after setting the field on fire with a promising…

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Novel Cholesterol Therapy Flops And Company Ends Development

–13 years after ApoA-1 Milano sparked excitement the novel HDL therapy appears to be dead. After 13 years and despite the efforts of 3 separate companies, the novel cholesterol therapy known as ApoA-1 Milano appears to be dead. On Monday afternoon the Medicines Company announced that it had discontinued development of the drug and would…

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Zombie Lab Sues Former Execs, Owners, And Sales Force

–Yet more fallout from the catastrophic bankruptcy of HDL Lab The Zombie Lab case just got even messier. Last Friday the trustee for the bankrupt Health Diagnostic Laboratory (HDL) filed a massive lawsuit against the former executives, owners, sales force members, and others who profited from HDL. The 205-page lawsuit includes a detailed narrative of…

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ACCELERATE Puts the Brake on CETP Inhibition

–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash…

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Studies Spotlight Role Of Triglycerides, Put HDL In The Background

Two new studies provide more evidence tilting the balance in favor of triglycerides rather than HDL playing a causative role in cardiovascular disease. But it is still too early to know whether the findings of any of the studies will point to useful new methods to prevent and treat disease. In the first study, published…

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Vampire Lab Turns To Old Trick To Grow Business: Physician Owned Labs

(Updated) True Health Diagnostics, the new laboratory that bought the assets and adopted the business model of the disgraced and bankrupt laboratory company Health Diagnostic Laboratory (HDL), is turning to some old, unethical, and illegal tricks to grow its business. As I’ve reported previously, one key to the spectacular growth of HDL laboratory involved surreptitious…

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The Real Losers In The Zombie Versus Vampire Lab Company Court Battle

(Updated) Right now a dead, bankrupt and corrupt laboratory company is suing an active, morally bankrupt lab company. No matter who eventually wins the court battle all of us– patients, Medicare, insurance companies, not to mention our entire health and legal systems– will lose. Health Diagnostics Laboratory (HDL) is the zombie lab company. After raking…

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A Lab Industry Veteran Deciphers The Zombie Lab Enigma

True Health Diagnostics (THD) is the new, rapidly growing lab that bought the assets of the disgraced and bankrupt Health Diagnostic Lab (HDL). (See the bottom of this story for links to my previous coverage of this story.) I asked one industry veteran for his thoughts on THD’s business practices and the relationship between THD…

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Zombie Laboratory Company Sics Bill Collectors On Patients Promised Free Tests

(Updated) In several short years Health Diagnostic Laboratory (HDL) achieved spectacular growth partially on the promise to customers that they would never be responsible for the high costs of the company’s tests. Now, after bankruptcy and a forced sale of the company following multi-million dollar lawsuits by the Federal government and large private insurance companies, those same…

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Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial

For the third time a large trial testing a CETP inhibitor drug has gone down the tubes. On Monday morning Eli Lilly announced that it had terminated ACCELERATE, its large phase 3 trial of the drug evacetrapib. The company said the trial was stopped “due to insufficient efficacy” and that the company planned to discontinue…

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HDL Raising Drugs Probably Won’t Work But This Might

A new study offers important new insights into the protective role of HDL cholesterol (the “good” cholesterol) against cardiovascular disease. Earlier studies with drugs that increase HDL levels, including niacin and CETP inhibitors, have not shown benefit. The new study suggests that simply increasing HDL levels isn’t the way to go. Instead, cholesterol efflux, the ability of HDL to…

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Cigna Sues Embattled HDL Laboratory For $84 Million

The Cigna Health and Life Insurance company is suing Health Diagnostic Laboratory Inc. for $84 million.  As reported previously, the embattled lab company is the subject of an ongoing Federal investigation concerning kickbacks and fraudulent billing. The charges against HDL in the suit filed last week in federal court closely echo the earlier allegations against the company….

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Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack!

Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals,…

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Beyond Kickbacks: More Questions About Unnecessary Cardiovascular Tests

On the front page of the Wall Street Journal today is an important story about a fast-growing company accused of giving kickbacks to physicians who order the company’s tests measuring a wide variety of cardiovascular biomarker tests. But the article leaves one major question unasked: even if the company played fully by the rules, are most of the tests medically…

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New Evidence Fuels Concerns About The Safety Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects. ……

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Large Genetic Studies May Help Unravel The Triglyceride Problem

The precise role of triglycerides in heart disease has been very difficult to determine. To help untangle the knotty problem two research groups studied large populations and identified rare variations in a gene (APOC3) that encodes for apolipoprotein C3, which is known to increase triglyceride levels. … The two studies have received a lot of…

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Another Failed HDL Therapy Trial

Despite robust epidemiological evidence suggesting that HDL has a strong protective effect against cardiovascular disease, there has been no good evidence showing that HDL-based therapies are beneficial. Large trials of drugs that raise HDL levels, including niacin and CETP-inhibitors, have failed to demonstrate improvements in outcome. Some observers gleaned hope from several small studies of…

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Slouching Toward Phase 3: Progress Report On New Cholesterol Drugs At The AHA

The American Heart Association meeting in Dallas this year brought new phase 2 data about several promising new cholesterol drugs. But before jumping on any bandwagons it would be good to remember that even for the drugs most far along in development we still haven’t seen any phase 3 data. In addition, it bears repeating that the…

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More Bad News For HDL Therapies: ASSURE Trial Misses Primary Endpoint

The string of bad news for HDL-related therapies continues. Resverlogix yesterday announced that the ASSURE clinical trial had failed to meet its primary endpoint. RVX-208, the drug being studied in the trial, is a novel small molecule that increases production of ApoA-1, which raises HDL levels and is thought to enhance reverse cholesterol transport. … Click here…

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WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children

There’s probably no greater public health issue than the long-term  consequences of the childhood obesity epidemic. So the Wall Street Journal should be commended for digging into some of the important science behind this problem in a feature article in today’s paper. The author, Ron Winslow, is widely regarded as the best working journalist who…

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Merck Starts To Suspend Worldwide Availability Of Tredaptive

In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Click here to read the full story on Forbes….

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Should Niacin Still Be Prescribed? William Boden Versus Harlan Krumholz

In the wake of HPS2-THRIVE many have argued that there is no longer any reason to prescribe niacin. William Boden, the lead investigator of AIM-HIGH and COURAGE, thinks there were enough flaws in the design of the niacin trials to justify the cautious use of niacin in certain circumstances. Says Boden: “There is evidence of…

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2012 In Review: A Bad Year For Conventional Wisdom

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…

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Early Look: New Methods To Enhance Cholesterol Efflux

Although clinical trials of HDL-boosting CETP inhibitors have so far failed to produce positive results, many other avenues of HDL-related research remain active.  A glimpse at the very early phases of two intriguing lines of research in this area was offered on Monday at the AHA. Apo A-1 is thought to be the key HDL…

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Dalcetrapib: Another HDL-Raising CETP Inhibitor Bites The Dust

Another HDL-raising CETP inhibitor has failed to demonstrate cardiovascular benefit in a large clinical trial. With the presentation of the dal-OUTCOMES trial at the American Heart Association in Los Angeles andsimultaneous publication in the New England Journal of Medicine, dalcetrapib joins torceptrapib on the list of once-promising CETP inhibitors. In dal-OUTCOMES, 15,871 patients with a recent…

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