–There’s broad agreement that non-HDL is a better measure than LDL. For decades lipid experts have been saying that non-HDL is preferable to LDL cholesterol in the assessment of cardiovascular risk. The subject is not controversial. Although they may disagree about its precise significance, every expert I contacted agreed that non-HDL is superior to LDL….
REVEAL Revealed: A Slightly Positive CETP Inhibitor Trial
August 29, 2017 by 3 Comments
—After 3 strikes a CETP inhibitor finally scores. BARCELONA — Finally there is a CETP inhibitor that actually confers more benefit than risk: anacetrapib. The benefit emerged from the Randomized EValuation of the Effects of Anacetrapib through Lipid-modification (HPS3/TIMI55-REVEAL) trial which was presented here at the European Society of Cardiology meeting and published simultaneously in…
End of the Road for CETP Inhibitors?
May 17, 2017 by 1 Comment
With the publication of the ACCELERATE trial in the New England Journal of Medicine the long train of bad and disappointing news for the once-promising approach of CETP inhibition remains unbroken. More than 12,000 high-risk patients were randomized in ACCELERATE to evacetrapib or placebo. In 2015 the trial was prematurely terminated for futility; the main…
Another HDL Therapy Crashes and Burns
March 19, 2017 by 3 Comments
–Failure of pre-beta HDL mimetic puts another nail in the HDL coffin Once again, an HDL-inspired therapy has failed when put to the test in a clinical trial. Although there are still ongoing trials with other HDL-related therapies, most experts now feel that it is time for the field to turn its attention elsewhere and…
Mixed Results For ApoA-1 Therapies
November 16, 2016 by Leave a Comment
–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…
Novel Cholesterol Therapy Flops And Company Ends Development
November 8, 2016 by Leave a Comment
–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…
Zombie Lab Sues Former Execs, Owners, And Sales Force
September 21, 2016 by Leave a Comment
–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…
ACCELERATE Puts the Brake on CETP Inhibition
April 3, 2016 by Leave a Comment
–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…
Studies Spotlight Role Of Triglycerides, Put HDL In The Background
March 11, 2016 by Leave a Comment
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…
Vampire Lab Turns To Old Trick To Grow Business: Physician Owned Labs
February 11, 2016 by 15 Comments
(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…
The Real Losers In The Zombie Versus Vampire Lab Company Court Battle
February 8, 2016 by Leave a Comment
(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…
A Lab Industry Veteran Deciphers The Zombie Lab Enigma
January 27, 2016 by Leave a Comment
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…
Zombie Laboratory Company Sics Bill Collectors On Patients Promised Free Tests
January 7, 2016 by 17 Comments
(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…
Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial
October 12, 2015 by 2 Comments
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…
HDL Raising Drugs Probably Won’t Work But This Might
November 18, 2014 by 1 Comment
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…
Cigna Sues Embattled HDL Laboratory For $84 Million
October 20, 2014 by Leave a Comment
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….
Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack!
October 17, 2014 by Leave a Comment
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,…
Beyond Kickbacks: More Questions About Unnecessary Cardiovascular Tests
September 8, 2014 by Leave a Comment
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…
New Evidence Fuels Concerns About The Safety Of Niacin
July 16, 2014 by Leave a Comment
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. ……
Large Genetic Studies May Help Unravel The Triglyceride Problem
June 19, 2014 by 1 Comment
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…
Another Failed HDL Therapy Trial
April 30, 2014 by Leave a Comment
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…
Slouching Toward Phase 3: Progress Report On New Cholesterol Drugs At The AHA
November 25, 2013 by Leave a Comment
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…
More Bad News For HDL Therapies: ASSURE Trial Misses Primary Endpoint
June 28, 2013 by Leave a Comment
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…
WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children
April 30, 2013 by Leave a Comment
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…
Merck Starts To Suspend Worldwide Availability Of Tredaptive
January 11, 2013 by Leave a Comment
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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