Scott Gottlieb’s Sham Ideology Rejects Clinical Trials

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…

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Clinical Trialists Dig In And Vote For Status Quo

–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…

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Eminence Based Medicine And Cardiac Surgery

Did a top surgeon perform a nonrandomized, semi-prospective, historically controlled clinical trial without IRB approval or patient consent? I don’t want to only pick on interventional cardiologists. Last week I wrote about a breathtaking case of interventional cardiology hubris. In response a prominent interventional cardiologist shared with me a fascinating anecdote about cardiac surgery. Here’s…

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Interventional Cardiology And The Rejection Of Science

–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,”…

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Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug

–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…

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Possible Setback For Califf On Road To FDA

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…

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A Premature SPRINT To The Finish Line

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…

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US Proposal Would Greatly Expand Transparency Of Clinical Trials

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.    …

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Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality

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…

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Early Success For Novel Novartis Heart Failure Drug

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…

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Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong

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…

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Why Is Actelion Suppressing Phase III Data?

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:…

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Hot Line Trials For European Society Of Cardiology Congress Announced

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.      …

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Get Ready For Munich: ESC Releases List Of Hot Line Sessions

Here is the list of Hot Line sessions scheduled for the European Society of Cardiology ESC) meeting in Munich:…

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