It’s “breakthrough” time again. News reports out of the Alzheimer’s Association International Conference (AAIC) this week have been relentlessly upbeat and positive about findings from the NIH’s SPRINT MIND study. The message: aggressive blood pressure control can help protect the brain. But unless you look very carefully at the news reports and “expert” statements you won’t…
No, A Big NIH Trial Did Not Show That Lowering Blood Pressure Will Prevent Dementia
July 26, 2018 by 4 Comments
CABANA: No Outcomes Benefit In First Big Trial Of AF Ablation
May 10, 2018 by 5 Comments
(Updated) Catheter ablation for atrial fibrillation (AF) produced no significant improvement in clinical outcomes in a large and important new clinical trial. CABANA is the first and long anticipated randomized controlled trial of AF ablation in the more than two decade long history of the procedure. The results will likely spark an intense controversy in…
More Controversy Over Major Cardiology Clinical Trial
March 30, 2018 by 7 Comments
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…
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…
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…
Principal Investigator Defends SPRINT Against Critics
April 20, 2017 by 1 Comment
–Blood pressure experts disagree about the NIH ‘Landmark’ Trial. Since the first announcement of its preliminary results the SPRINT trial has been the focus of intense controversy. One major focus of contention revolves around the precise technique used to measure blood pressure in the trial. As in all recent large outcome trials in hypertension, blood…
SPRINT: More Controversy And Confusion About ‘Landmark’ Trial
September 6, 2016 by 3 Comments
–Blood pressure experts raise new questions and concerns about the controversial trial. More questions and concerns are being raised about SPRINT, the NIH’s “landmark” blood pressure lowering trial. In sharp contrast to the enormous amount of initial hype, many hypertension experts are now saying that the SPRINT trial is difficult to interpret and can’t be readily…
Waiting For ISCHEMIA: Why Won’t Cardiologists Enroll Patients?
November 8, 2015 by Leave a Comment
One of the most important unanswered questions in medicine today– the best treatment for stable ischemic heart disease– may never get a satisfactory answer because cardiologists are unwilling to enter their patients in a clinical trial. One major reason why the question is urgent: about a third of the 1 million PCI procedures performed each year in the…
Coming Attraction: Looking Forward To SPRINT At The AHA Next Month
October 27, 2015 by Leave a Comment
Back in September the NIH tantalized the medical community with a preliminary announcement of the results of a major clinical trial, SPRINT (Systolic Blood Pressure Intervention Trial). The NIH said SPRINT was a “landmark trial” that could “save lives,” but their claims were impossible to evaluate since they only gave the slightest hint of the actual results. On November…
Heart Failure Experts SPRINT To An Early Finish
October 7, 2015 by Leave a Comment
According to a recent news report a group of prominent heart failure doctors have eagerly embraced a lower blood pressure target of 120 mm Hg for heart failure patients based on the preliminary results of the SPRINT trial announced last month. But another equally prominent heart failure doctor says that it is far too early to…
SPRINT Trial To Be Presented At The American Heart Association Meeting In November
September 29, 2015 by Leave a Comment
Update: I have now received confirmation that SPRINT will be presented on Monday, November 9 at 2 PM. The SPRINT trial, which provoked a storm of excitement and controversy a few weeks ago, will be presented in November at the American Heart Association meeting in Orlando. The trial is not currently on the list of late-breaking clinical trials but…
Second Trial Of Controversial Chelation Therapy Gains Crucial Early Support
September 28, 2015 by 3 Comments
The National Institutes of Health is giving money to support the planning of a second trial to test the potential role of chelation therapy in treating patients with myocardial infarction. The first Trial to Assess Chelation Therapy (TACT) was extremely controversial. It was funded by the NIH more than a dozen ago as part of an initiative to…
NIH Trial, Stopped Early, Supports More Intensive Blood Pressure Targets
September 11, 2015 by Leave a Comment
More stringent blood pressure targets could save lives and reduce cardiovascular events, according to preliminary results from a large NIH clinical trial that was stopped early. The SPRINT (Systolic Blood Pressure Intervention Trial) trial randomized 9,361 hypertensive patients 50 years of age or older to the standard systolic blood pressure target (when the trial began) of 140…
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. …
Controversial NIH Chelation Trial Published In JAMA
March 26, 2013 by Leave a Comment
Final results of the troubled NIH-sponsored TACT trial testing chelation therapy for coronary disease have now been published in JAMA. Last November, when the preliminary results were presented at the American Heart Association meeting, the positive finding in favor of chelation therapy surprised many observers, though the investigators and senior AHA representatives expressed considerable caution about the proper…
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