New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs

More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…

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Should Doctors Tell Patients They Are Walking Time Bombs?

Updated– Should doctors tell patients that they are walking time bombs? We all know this is a commonly used metaphor. When it comes to the heart people are often told they have a “ticking” time bomb. Here’s one recent very public example from a story about statins by Jane Brody in the New York Times: “My friend Richard…

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Clot Extraction For Stroke: Beware The Hype

Clot extraction (thrombectomy) for stroke has been on a roll lately. After the failure of a series of trials a few years ago investigators and industry went back to the drawing board. The result of their efforts– a new and improved thrombectomy– has brought about a dramatic reversal of fortune for the technology. In the past year five newer trials…

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Slow Start For New Novartis Heart Failure Drug Entresto

Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be…

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Trick Or Treat? Hospitals, Haunted By DOJ ICD Investigation, Settle For $250 Million

The specter of the US government investigation into hospital overuse of ICDs has now finally been dismissed. The investigation, which has haunted hospital executives and electrophysiologists since it began in 2011, was finally resolved on the day before Halloween. With a $250 million treat for the government the hospitals have now finally managed to get the unwelcome trick or treaters…

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Studies Suggest Flu Vaccines May Be Less Effective In People Taking Statins

Two new studies published in the Journal of Infectious Diseases offer preliminary evidence that the flu vaccine may not work as well in people taking statins. But there is widespread agreement among experts that the association, much less a demonstration of cause and effect, has not been proven, and that current clinical practice should not be changed because…

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Does Anyone Really Think Industry Funded CME Is Independent?

Does anyone really think that commercially supported continuing medical education (CME) is truly independent? Or does anyone really think that it has the primary goal of delivering quality medical education? A few weeks ago John Fauber and colleagues wrote an important story in the Milwaukee Journal-Sentinel and MedPage Today about the role of CME in helping…

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Coming Attraction: Looking Forward To SPRINT At The AHA Next Month

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…

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Amgen Requires Patients in Repatha Copay Program To Surrender Their Privacy

(This story was updated on October 23 with a statement from Amgen. It was again updated on October 27 with new information about Amgen’s patient privacy policy for a second drug, Enbrel.) (For an important followup to this story please see:  Amgen Takes The Pledge To Respect Patient Privacy) The tumult over the new cholesterol…

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New Analysis Finds Small But Significant Advantage For Low Carb Diets

A new meta-analysis finds that low-carb diets are more effective than low-fat diets in weight loss and reducing cardiovascular risk. The study finding suggests “that a low-carb diet should be the first line approach for weight management,” said the first author of the study, Jonathan Sackner-Bernstein. But the difference between the two dietary approaches was not…

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Primary PCI Guideline Update: Multivessel Interventions In, Thrombectomy Out

The guidelines for primary PCI for ST-elevation MI (STEMI) have been updated to reflect major findings from recent trials: PCI of a noninfarct artery is now acceptable for some STEMI patients with multivessel disease. In previous guidelines PCI of noninfarct arteries had been considered unsafe. Routine thrombectomy prior to primary PCI for stent implantation is now…

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More Questions About Nonprofit Groups And Industry Support

In response to my article about commercial funding of nonprofit organizations from the manufacturers of the PCSK9 inhibitors, Joshua Knowles wrote an eloquent and heartfelt defense of the FH Foundation, which receives some funding from industry. But I think he fails to address the fundamental underlying issues I wrote about in my piece. Knowles writes that “FH is a…

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New York Times: Indiana Cardiologist Accused Of Performing Unnecessary Procedures

Just when you thought it was safe to read the paper again, along comes a New York Times report suggesting that not all cardiologists have learned the seemingly obvious lessons from the overuse scandals from the past decade. In a front page article in Sunday’s business section, Julie Creswell writes about the ongoing controversy and scandal involving cardiologist Arvind Gandhi,…

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Low T And High BS: The Role of CME

Most of my readers are keenly aware of the explosion in the marketing of testosterone products in recent years. Now a joint investigation from the Milwaukee Journal Sentinel and MedPage Today uncovers the key role played by continuing medical education (CME) programs funded by companies that make prescription testosterone products. The story, by reporters John Fauber, Coulter…

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Praising The Virtues Of The Familial Hypercholesterolemia Foundation

The following letter was sent by Joshua Knowles in response to a previous post, Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers. Dr. Knowles is a faculty member and clinician at Stanford University who specializes in familial hypercholesterolemia. He is also the chief medical advisor for the FH Foundation. Dear Mr. Husten, I…

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What If The Media Covered The World Series The Same Way It Covers Science?

Note: This is a slightly updated version of an old post. I think it is especially relevant at this time of year. October brings the Nobel Prize announcements and the World Series. No one will mistake media coverage of one for the other. Each Nobel Prize will get one article and 10 seconds on the…

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Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers

Everyone expects that the makers of the new PCSK9 inhibitor cholesterol lowering drugs are going to make billions and billions of dollars from these innovative new drugs. But before that can happen the companies that make the drugs will need to find the patients who will take the drug. To help find these patients a central strategy…

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But Cardiomyopathy Isn’t Supposed To Be Funny

Cardiomyopathy isn’t funny. In fact, sad to say, most of medicine isn’t exactly a laugh riot. But Jorge Muniz, a physician assistant and comic artist, wants to bring humor to medical education. Here’s a link to his kickstarter campaign.  …

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The Expanding Universe: JAMA Announces New Cardiology Journal

Warning: snark and cynicism ahead. I’ve said it before and I’ll say it again: what the world needs now is another cardiology journal. And so, as if they were reading my mind and the collective mind of the cardiology community, the AMA announced today the launch of a new journal, JAMA Cardiology. The editor-in-chief will…

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Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial

For the third time a large trial testing a CETP inhibitor drug has gone down the tubes. On Monday morning Eli Lilly announced that it had terminated ACCELERATE, its large phase 3 trial of the drug evacetrapib. The company said the trial was stopped “due to insufficient efficacy” and that the company planned to discontinue…

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New Test May Allow Early Discharge Of Chest Pain Patients

Each year in the US about six million people go to the emergency department with chest pain or other symptoms suggesting that they might be having a heart attack or other acute coronary syndrome (ACS). The vast majority of them do not have ACS, but because it is difficult to quickly rule out ACS many of them end…

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‘Cardiology On A Collision Course With Specialty Pharmaceutical Pricing Models’

The recent approval of two new expensive cholesterol drugs “sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models that were previously reserved for drugs that benefited relatively limited patient populations,” according to the authors of a perspective published in the New England Journal of Medicine. Until now cardiologists and other doctors treating the…

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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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Heart Failure Experts SPRINT To An Early Finish

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…

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New Cholesterol Drugs Gain Entry To Large Formulary

The two big and expensive new cholesterol drugs that everyone is talking about have both been added to the national preferred formulary of Express Scripts, the nation’s largest pharmacy benefit manager. The drugs– alirocumab (Praluent, from Regeneron and Sanofi) and evolocumab (Repatha, from Amgen)– are potent but expensive drugs that inhibit PCSK9 and dramatically lower LDL cholesterol. Both drugs…

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