Think about this: A new article reports that a major NIH-funded trial runs into trouble. The article raises all sorts of fundamental questions about our ability to perform meaningful clinical research. But instead of expressing concern about these legitimate problems, medical leaders ignore these questions and instead focus their ire and criticism on the article authors,…
Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial
March 18, 2018 by 4 Comments
As a major clinical trial in cardiology nears completion it has provoked a storm of criticism and controversy. The brouhaha erupted in response to a late change to one of the most important— and already controversial— trials in cardiovascular medicine. The NIH-funded ISCHEMIA trial was designed back in 2011 to provide a definitive answer to…
Moment Of Truth For Struggling And Expensive Cholesterol Drugs
February 15, 2018 by 7 Comments
It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…
Ethical Questions Raised About NIH Blood Transfusion Trial
August 4, 2017 by Leave a Comment
–Public Citizen says the MINT trial comparing blood transfusion strategies after MI should be halted. Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy…
Recent Blow Ups Spark Call For Overhaul Of Clinical Trials
May 11, 2017 by 2 Comments
[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…
Another Acute Heart Failure Drug Fails In Large Clinical Trial
May 5, 2017 by 2 Comments
–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…
As Another Trial Goes Bust Investigators Call For Major Changes In International Trials
April 29, 2017 by 2 Comments
–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…
Serious Questions Raised About Integrity Of International Trials
April 26, 2017 by 4 Comments
–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…
Can SPRINT Be Used To Inform Hypertension Treatment?
April 9, 2017 by 3 Comments
–The landmark trial results are not easy to apply to clinical practice. Since the first breathless announcement of its preliminary results, SPRINT trial has been viewed as a landmark trial serving to establish a more aggressive approach to blood pressure management. It is now becoming increasingly clear, however, that the application of SPRINT in the…
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
March 14, 2017 by 3 Comments
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
Clinical Trialists Dig In And Vote For Status Quo
August 5, 2016 by Leave a Comment
–Doctors who got famous for doing clinical trials resist changes to the clinical trial system. It should probably come as no surprise that hundreds of clinical trial investigators whose positions and livelihoods depend largely on the existing clinical trial system have expressed great reluctance and annoyance at a proposal that could radically shake up that system. As…
Interventional Cardiology And The Rejection Of Science
July 22, 2016 by 6 Comments
–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”…
Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug
May 19, 2016 by Leave a Comment
–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but slow starting heart failure drug Entresto (valsartan/sacubitril). The company said it would perform 40 clinical trials with the drug in the next five years. The Fortifying Heart Failure clinical evidence and…
Possible Setback For Califf On Road To FDA
October 7, 2015 by Leave a Comment
Rob Califf may have just run into his first serious roadblock on his path to become the FDA’s next commissioner. According to a report in the Boston Globe, Califf removed his name as a co-author from a series of papers, some of which were critical of current FDA policy. Until now Califf’s nomination has not encountered a…
A Premature SPRINT To The Finish Line
September 14, 2015 by 1 Comment
On Friday the NHLBI declared victory in the SPRINT trial. As was widely reported here and elsewhere, the NHLBI announced that the trial had been stopped early after significant reductions in cardiovascular events and mortality had occurred in the group of hypertensive patients randomized to a more aggressive blood pressure target than is currently recommended today. But there was a…
US Proposal Would Greatly Expand Transparency Of Clinical Trials
November 19, 2014 by Leave a Comment
The US Department of Health and Human Services today proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to report. … Click here to read the full post on Forbes. …
Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality
March 31, 2014 by 1 Comment
The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s two primary investigators. Earlier today I reported that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early because the trial had demonstrated…
Early Success For Novel Novartis Heart Failure Drug
March 31, 2014 by Leave a Comment
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and…
Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong
February 20, 2014 by Leave a Comment
In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering…
Why Is Actelion Suppressing Phase III Data?
December 6, 2013 by 2 Comments
I highly recommend a terrific article by Ian Parker in this week’s New Yorker about Merck’s efforts to develop a novel insomnia drug, suvorexant. Normally I don’t write about non-cardiology topics but I want here to call attention to one small, almost tangential detail buried in the middle of the story. It’s not about the Merck drug but about another orexin antagonist from Actelion, almorexant:…
Hot Line Trials For European Society Of Cardiology Congress Announced
June 18, 2013 by 1 Comment
The European Society of Cardiology has published the full program for the 2013 Congress taking place in Amsterdam from August 31 through September 4. There will be 4 Hot Line Sessions. Here is the schedule for Hot Line trials: … Click here to read the full post on Forbes. …
Get Ready For Munich: ESC Releases List Of Hot Line Sessions
July 6, 2012 by Leave a Comment
Here is the list of Hot Line sessions scheduled for the European Society of Cardiology ESC) meeting in Munich:…
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