A journalist who has been a frequent critic of statins has been publicly accused of scientific misconduct involving image manipulation in an earlier research paper. Maryanne Demasi is an Australian journalist who has a PhD in Rheumatology from the Royal Adelaide Hospital in South Australia. She has been a frequent critic of statins, a proponent of…
More Mini-Trials And Fewer Mega-Trials?
January 2, 2018 by 5 Comments
Just as dinosaurs ruled the earth for millions of years, for more than 30 years now cardiology has been ruled by mega-trials. Over the years the cardiology landscape would shake and tremble as ever more gigantic mega-trials emerged to dominate the field. Just as the giant dinosaurs paid no attention to the seemingly inconsequential little…
New Economic Analyses Fail To Make Case For PCSK9 Inhibitors
August 23, 2017 by 1 Comment
(Updated) –PCSK9 inhibitors have ‘the dubious distinction of being the most expensive preventive therapies by far in the history of cardiovascular medicine’ Two new economic analyses conclude that PCSK9 inhibitors are far too expensive to be cost effective. Both studies incorporate data from FOURIER, the first and still the only large cardiovascular outcomes trial with…
Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market
August 8, 2017 by 2 Comments
–Drug company dreams up a study showing all the benefits and none of the costs or risks of PCSK9 inhibitors. Here’s a pro tip for pushing a drug (or, indeed, any aggressive treatment or screening strategy): focus exclusively on the benefits, even if they are modest at best, and completely ignore side effects and costs….
How Statins Make Some People Crazy
July 30, 2017 by 21 Comments
–Intelligent discussion about statins is threatened by zealous partisans. What is it about statins that causes so many people to go crazy? I’m not talking about any pharmacological effect of the drugs. Instead my focus here is on the zealous partisans— both against and in support of statins— who go off the deep end. Unfortunately…
Nissen Calls Statin Denialism A Deadly Internet-Driven Cult
July 24, 2017 by 15 Comments
–“We are losing the battle for the hearts and minds of our patients.” A leading cardiologist has unleashed a blistering attack on “statin denial,” which he calls “an internet-driven cult with deadly consequences.” In an editorial in Annals of Internal Medicine, Steve Nissen (Cleveland Clinic) expresses grave concerns over statistics showing that only 61% of…
Study Estimates Benefits Of Broad Primary Prevention Strategies With Statins
July 20, 2017 by 9 Comments
–But the benefits may be substantially diminished when patient preferences are considered. A new analysis provides staunch support for the use of statins for the primary prevention of cardiovascular disease. But the same analysis also emphasizes that this support varies dramatically based on the values and concerns of individual patients. Kirsten Bibbins-Domingo (UCSF) led a…
Study Fuels Debate Over When to Start Cholesterol Screening
May 15, 2017 by 3 Comments
–For younger adults, study finds low yield of 10-year risk-based screening A new study provides ammunition to supporters of a conservative approach to initiating cholesterol tests in younger adults. But proponents of a more aggressive approach argue that the interpretation does not take into account the enormous burden of cardiovascular disease as people grow older….
Rigorous Study Debunks Alarms That Statins Cause Muscle Problems
May 2, 2017 by 16 Comments
(Updated, May 2, May 4) –The authors say muscle problems with statins are an example of the ‘nocebo’ effect. A new study helps debunk the widespread belief that statins cause muscle-related pain and weakness in large numbers of patients. The “nocebo effect” may be the cause of the epidemic of muscle pain among statin users,…
27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints
February 2, 2017 by 3 Comments
(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…
Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors
November 30, 2016 by 2 Comments
–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…
Statin Nation ‘Census’ Highlights Major Disparities
November 14, 2016 by Leave a Comment
–Women, minorities treated at significantly lower rates Anyone reading this is almost certainly aware of the enormous importance of statins in the current health scene. But until now they may have had a hard time to bring precise numbers and statistics to this all important story. Now data from a large federal survey confirm that…
No Cognitive Benefit from Heart Drugs in HOPE-3
November 13, 2016 by Leave a Comment
–Substudy finds mental function unimproved by BP, cholesterol treatments NEW ORLEANS — A large substudy of the HOPE-3 trial found no benefit relating to cognitive function in patients who took cholesterol or blood pressure-lowering drugs. In recent years cognitive decline and dementia have emerged as a concern equal if not even greater than cardiovascular disease…
Debate Ensues As USPSTF Finalizes Statin Primary Prevention Guideline
November 13, 2016 by Leave a Comment
–Broad disagreement about how, when, and if to use statins. The U.S. Preventive Services Task Force (USPSTF) has issued final recommendations regarding the use of statins for primary prevention of cardiovascular disease in adults. The recommendations, first proposed last December, are broadly consistent with the 2013 American College of Cardiology/American Heart Association guidelines. But accompanying the…
The Lancet Versus BMJ: Dispatch From The Statin Wars
September 15, 2016 by 5 Comments
–The editors of the two top UK medical journals are in a bitter fight over statins. The editors of the two top medical journals in the UK are at war over statins. The bitter fight has its origins in the 2014 publication in the BMJ of two articles that were highly critical of statins. Rory…
Statin Trialists Seek To Bury Debate With Evidence
September 8, 2016 by 14 Comments
–A Lancet review claims overwhelming evidence in favor of statins for both primary and secondary prevention. Some disagree. A large group of statin researchers argue forcefully that the debate over statins should be ended because the evidence in favor of statins is overwhelming and incontrovertible. But some outsiders say the issue is more nuanced and…
Bad News Bears: After Scary Headlines Some Patients Stopped Taking Statins
June 28, 2016 by 2 Comments
Study provokes discussion about the responsibilities of medical journals and the general media. A new study and surrounding discussion raises important questions about the role and responsibility of researchers, editors, and journalists when tackling topics with potentially life-affecting consequences. The new study, published in the BMJ, found that many people stopped taking statins in the…
Study Questions ‘Lower Is Better’ For Cholesterol
June 20, 2016 by 3 Comments
–No added benefit for statin patients who reached very low LDL levels A large observational study suggests that moderate lowering of LDL may be just as effective as intensive lowering. “Our results do not provide support for a blanket principle that lower LDL cholesterol is better for all patients in secondary prevention,” the authors conclude….
Cholesterol Skeptics Launch Another Attack
June 15, 2016 by 8 Comments
–But most experts say their study is highly flawed Once again, a group of cholesterol skeptics has published an inflammatory attack on the cholesterol hypothesis. But critics say that the paper is deeply flawed and should not be used to influence treatment or policy decisions. In a paper published in BMJ Open, Uffe Ravnskov, MD,…
Increasing Support For Generic Drugs And Therapeutic Substitution
May 9, 2016 by Leave a Comment
–But some physicians, perhaps influenced by industry, remain skeptical. Generic drugs and therapeutic substitution (replacing a drug without a generic equivalent with a different but closely related drug in the same general class) are two key ingredients in most recipes to hold down health care costs. Now a package of articles and commentary in JAMA…
Experts Foresee Major Role For Generic Crestor
May 2, 2016 by Leave a Comment
— Finally there’s a challenger to the long reign of Lipitor The FDA approval on Friday of the first generic version of Crestor (rosuvastatin calcium) marks the end of an era and the beginning of a major shift in cardiovascular medicine. Over time, as the price of the drug drops with generic competition, it seems…
FDA Ends Niacin and Fenofibric Acid Combinations With Statins
April 17, 2016 by 4 Comments
–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…
How Does HOPE-3 Change Thinking About Primary Prevention?
April 2, 2016 by 5 Comments
–The study lends strong support for statins but delivers a mixed message for antihypertensives. The widely reported results of HOPE-3 may bolster the case for primary prevention with statins and blood pressure drugs. But the trial also makes clear that the benefits, though real, are also modest, and may not be evenly distributed between statins…
Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe
December 10, 2015 by 1 Comment
You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…
Experts Question Role For At-Home Statin Intolerance Test
November 22, 2015 by Leave a Comment
A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…
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