How True Is the Science of Clinical Trials?
Majid Ali, M.D.
Shockingly Untrue. Please Read This Article and Decides for Yourself.
I read two short reports on page 269 of the journal Nature of 20 August, 2015. The answer followed the question almost instantly. The first report firmly established that none of the conclusions drawn from clinical trials of drugs for treating heart disease (the so-called evidence-based cardiology) can be considered free of distortions and deceptions.
Strong words! Yes they are. Please read the whole article before deciding if my strong words are frivolous or they are truly needed.
Only One in Seven Trials Trustworthy
Briefly, the first report in the journal Nature revealed that the rate of positive effects found in trials of heart disease treatments fell from 57% in trials started before 2000 to just 8% in trials beginning after that year. That was when when the government imposed higher standards for documentation (see details in the text from Nature reproduced at the end of the article).
The problems: Only one of seven pre-2000 trials were trust worthy but cardiologists had no way of separating honest from dishonest trials. Nor can do they do so retrospectively.
HDL Protein, Not Cholesterol, Found To Be the Real Thing
The second Nature report concerns the anti-inflammatory effects of one component of HDL (high density lipoprotein) called SIP, which by its anti-inflammatory effects adds to the natural mechanisms for the prevention of heart disease. This adds to the evidence against the false notion that the so-called ‘good’ HDL cholesterol prevents heart disease.
There is only one cholesterol, with one one molecular formula and one three-dimensional molecular architecture. It is that simple. It is silly to call the same cholesterol molecule ‘good’ and ‘bad’ to promote selling cholesterol statin drugs. I discuss the crucial subject at length in my FREE Cholesterol Course at this web site.
These are strong words. Below I offer brief comments for the general reader and the reproduce the two short reports verbatim from the journal Nature for professional readers. I welcome their opposing views, if any, and will share them with all readers.. (My e-mail for this is email@example.com)
I offer the following FREE courses for interested readers posted at this site as well as at http://www.aliscience.og
- Dr. Ali’s Heart Course
- Dr. Ali’s Cholesterol Course
- Integrative Cardiology, the 6th volume of my 14-volume textbook The principles and Practice of Integrative Medicine entitled Integrative
- WoolstonRegistered clinical trials make positive findings vanish. Chris Woolston. Nature. 2015:524:269 (20 August, 2015)
- Good cholesterol gets even better. Nature;524:260.
- Science Signal. 8, ra79 (2015)
Text of the First Nature Report
The launch of the clinicaltrials.gov registry in 2000 seems to have had a striking impact on reported trial results, according to a PLoS ONE study1 that many researchers have been talking about online in the past week.
A 1997 US law mandated the registry’s creation, requiring researchers from 2000 to record their trial methods and outcome measures before collecting data. The study found that in a sample of 55 large trials testing heart-disease treatments, 57% of those published before 2000 reported positive effects from the treatments. But that figure plunged to just 8% in studies that were conducted after 2000. Study author Veronica Irvin, a health scientist at Oregon State University in Corvallis, says this suggests that registering clinical studies is leading to more rigorous research. Writing on his NeuroLogica Blog, neurologist Steven Novella of Yale University in New Haven, Connecticut, called the study “encouraging” but also “a bit frightening” because it casts doubt on previous positive results.
Irvin and her co-author Robert Kaplan, chief science officer at the Agency for Healthcare Research and Quality in Rockville, Maryland, focused on human randomized controlled trials that were funded by the US National Heart, Lung, and Blood Institute (NHLBI). The authors conclude that registration of trials seemed to be the dominant driver of the drastic change in study results. They found no evidence that the trend could be explained by shifting levels of industry sponsorship or by changes in trial methodologies.
Text of the Second First Nature Report
The molecule that removes cholesterol from arteries could have another protective effect in heart disease: curbing inflammation.
High-density lipoprotein (HDL; known as the ‘good cholesterol’) transports fat from blood-vessel walls to the liver for excretion. But it also carries the fatty signalling molecule S1P, which activates the anti-inflammatory receptor S1P1. Timothy Hla of Cornell University in New York and his colleagues tested the effect of HDL-bound S1P on cells that line human blood vessels and found that it dampened inflammation. In mice engineered to develop heart disease, those missing the S1P gene had more arterial plaques than did those with the gene.
The researchers think that this further explains the ability of HDL to stave off cardiovascular disease.