Amarin Begins Legal Off-Label Promotion Of Vascepa

Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product, Medical Marketing & Media reports. Vascepa was first approved by the FDA in 2012 as as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL),…

Click here to continue reading…

Don’t Believe The Hype

What is the most common flaw in health journalism? “Conveying certainty that doesn’t exist.” That’s Gary Schwitzer’s terrific response to this important question. At last week’s Presenting Overdiagnosis 2015 conference in Washington, DC Schwitzer, the publisher of HealthNewsReview.Org, listed the most common mistakes journalists make: Exaggerating effect size– relative not absolute data Using causal language to describe observational studies Idolatry…

Click here to continue reading…

Report Concludes That PCSK9 Inhibitors Are Effective But Very Expensive

The new PCSK9 inhibitors– with an annual cost of over $14,000 a year– are far too expensive to be broadly used in eligible populations without restrictions, according to a draft report from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to…

Click here to continue reading…

Growing Problem: When Should Drugs Be Discontinued?

There is an entire medical-industrial complex devoted to discovering and testing drugs to treat cardiovascular disease. Unfortunately there is a near complete absence of efforts to figure out if and when these same drugs should be discontinued. Consider Desmond Julian. The very distinguished cardiologist has been nearly killed by his profession on multiple occasions. In a State-of-the-Art…

Click here to continue reading…

Crystals, Spiritual Speed Dating, And The New York Times

Once again the New York Times has published a story that contains pseudoscientific, completely unsupported health claims without providing any critical perspective on the topic. A few weeks ago I wrote an open letter to the New York Times Public Editor about an egregious article in the Style and Fashion section about sound bath “healers.” Now the Times has once again…

Click here to continue reading…

It’s Complicated! Large Genetic Study Of Coronary Disease Shows How Much We Don’t Know

We still have a very long way to go before we understand the genetic underpinnings of coronary artery disease, according to the largest and most comprehensive study in the field performed to date. In a series of tweets Sekar Kathiresan, a co-leader of the study, summarized the  meta-analysis of genome-wide association studies, which was published in Nature Genetics: Our…

Click here to continue reading…

No Increase In Diabetes Found With Ezetimibe In IMPROVE-IT

A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe. Michael Blazing of Duke University presented the results of the IMPROVE-IT substudy on Tuesday afternoon at the European Society of Cardiology meeting in London. The analysis was prompted by previous findings from very…

Click here to continue reading…

Califf, Nissen, And Others Agree And Disagree About Regulatory Standards

Everyone agrees. A panel of US and European cardiologists, regulators, and industry executives agreed broadly that regulatory standards for drugs and devices need to be rigorous enough to prevent harm to patients. And, they also agreed, the standards shouldn’t be so strict that they stifle innovation. The problem, of course, is how to find the right…

Click here to continue reading…

IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics

The beneficial effects of ezetimibe are found almost exclusively in  patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…

Click here to continue reading…

Novel Drug Could Cut LDL With Just 2 Or 4 Shots A Year

A novel drug still in phase 1 studies could dramatically lower cholesterol with only a few injections each year. Because the drug could be given during regular visits to the doctor it might help solve the thorny problem of drug compliance and adherence. Like the recently approved monoclonal antibodies alirocumab and evolocumab, the drug targets PCSK9 to lower LDL,…

Click here to continue reading…

Hot Lines, Simultaneous Publications, And The Decline Of Medical Meetings

Back in the Dark Ages when I covered big medical conferences (like the European Society of Cardiology meeting now getting underway in London) it was necessary to attend the sessions, roam the halls, and talk to doctors. There were no late-breaking or hot line sessions and there were certainly no simultaneous publications in journals. (If memory…

Click here to continue reading…

Cholesterol Wars: The Reimbursement Battle Begins

(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…

Click here to continue reading…

ESC 2015 Set To Start In London

The European Society of Cardiology meeting starts this weekend in London.   Merrie Olde Englande?   Industry will be here too.  …

Click here to continue reading…

FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s  Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…

Click here to continue reading…

Labor Union Targets American Heart Association For Financial Conflicts

Unite Here, a labor union with 270,000 members, is attacking a surprising target, the American Heart Association. A report released by the group— entitled “Is the American Heart Association for sale?”– cites multiple examples of financial conflicts of interest involving prominent leaders of the organization. Among the major accusations in the report: Robert Eckel, a former AHA president…

Click here to continue reading…

Ignorance, Cardiology, And The Milky Way Galaxy

Question: How is the Milky Way Galaxy like cardiology (and the rest of medicine and science)? Answer: Sometimes we think we know a lot more about them than we really do. I remember staring at the page of my third grade science textbook. We were learning about astronomy and the Milky Way galaxy. There was…

Click here to continue reading…

FDA Approval Of Second PCSK9 Inhibitor Expected Soon

The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…

Click here to continue reading…

All The Woo That’s Fit To Print: An Open Letter To The New York Times Public Editor

Dear Public Editor, Why does the New York Times continue to allow fashion and style reporters to write stories that contain preposterous scientific and medical statements without providing any outside perspective from, say, real scientists or doctors? A recent and egregious case is “Sound Baths Move From Metaphysical to Mainstream” by Sophia Kercher  (August 15, 2015), which repeats a string of…

Click here to continue reading…

Cookie Monster, Free Lunch, And The New England Journal Of Medicine

In its efforts to defuse the conflict of interest issue the New England Journal of Medicine keeps setting off new explosions. The recent series of articles by Lisa Rosenbaum in the New England Journal of Medicine about conflict of interest issues provoked a storm of debate, including a powerful response from three former NEJM editors (and my own more eccentric response). Now NEJM itself has published…

Click here to continue reading…

Wow! Maybe– Finally– A Positive Diabetes Drug Outcomes Trial

Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical…

Click here to continue reading…

Farewell To Forbes: No, I Am Not Dr Oz, Nor Was Meant To Be

Note to readers: The following post was just published on Forbes. As it explains, the content published here will no longer run simultaneously on Forbes.  In case there’s any confusion: I am no Dr. Oz. I am not fantastically good looking, despite what my mother says. I’m not a cardiac surgeon and, of course, I don’t have a wildly popular…

Click here to continue reading…

The Amarin Decision: Free Speech Or Truthiness?

Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description…

Click here to continue reading…

What Role Should Coca-Cola Play In Obesity Research?

The New York Times reports that Coca-Cola gives financial support to scientists and a new foundation to help promote the message that the obesity epidemic is fueled not by too many calories or too much sugar but by not enough physical activity. The Times piece is well worth a read but the issue it takes up is not new.  Last year I wrote a…

Click here to continue reading…

Doctor Scorecards: The Wrong Answer To The Right Question

ProPublica’s recent publication of a Surgeon Scorecard has drawn intense criticism from many doctors. Without going into details here, I think it’s fair to say that many of the critics’ points are valid. Even its strongest defenders agree that the Scorecard is far from perfect. I’m not sure I have much to add to the discussion…

Click here to continue reading…

$300 Millions Dollars Of Cardiology Sunshine

$300 million dollars. That’s how much industry paid to cardiologists and other related healthcare professionals between August 2013 and December 2014… … Click here to read my entire story on MedPage Today….

Click here to continue reading…