FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Repatha

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…

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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…

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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…

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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…

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The Amarin Decision: Free Speech Or Truthiness?

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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…

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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…

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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…

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Fact Check: NY Times Heart Disease Series Gets It Right– Mostly

In my opinion Gina Kolata, who writes for the New York Times, is the most extravagantly talented and gifted  health and science reporter working today. Her virtues are abundantly evident in Mending Hearts, a four-part series about several major developments and controversies involving the treatment of heart disease. You should read it right away. You’ll learn a lot….

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Embattled Laboratory Files For Bankruptcy

Health Diagnostic Laboratory, Inc., the embattled lab company, has filed for chapter 11 bankruptcy. The once high flying company, which was founded in 2009 and achieved annual revenue of more than $400 million in a few short years, has been beset by scandal and legal difficulties. Most recently, the US Department of Justice announced that it had reached a…

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Get A Grip! Global Study Shows Grip Strength Is a Simple And Powerful Predictor Of Death

A large global study finds that grip strength is a simple, powerful, and broadly applicable test that can help predict the risk of death and cardiovascular disease. The new findings from the Prospective Urban-Rural Epidemiology (PURE) study were based on data from nearly 140,000 adults in 17 countries. The study participants had their grip strength…

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Diet Drug Study Crashes And Burns In The Wake Of Leaked Results

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early…

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Prominent Harvard Cardiologist Moves To Google X To Head Large Study

Here’s a clear sign of the ascending role of digital/precision/personalized medicine: a prominent cardiologist has left a top academic and clinical position in Boston to run a large, innovative study in Silicon Valley. Jessica Mega was widely perceived as a rising star at Harvard Medical School and the Brigham and Women’s Hospital. She has now joined Google X, Google’s research arm,…

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Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use…

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Precision Medicine Approaches Peak Hype

No, Personalized Medicine Isn’t Going To Save $600 Billion Over 50 Years By Preventing Heart Disease The hype over personalized medicine has now reached astonishing new heights.  In an article published in the Lancet, Victor Dzau, the new president of the Institute of Medicine, and coauthors write that personalized and precision medicine (PPM) could deliver hundreds of billions of dollars worth…

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200-Year-Old Heart Drug Linked To Increased Risk Of Death

For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin.  Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there…

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More Evidence Linking Sugared Drinks To Diabetes

A new study uncovers some potentially important new details about the association between sugared drinks and diabetes. In a paper published in Diabetologia [pdf], researchers in the UK report on a study of more than 25,000 adults. Over the course of more than 10 years of followup 847 participants went on to develop diabetes. Instead of relying on a food…

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No Benefit For A Commonly Used Cardiac Device

Once again, after decades of common use, a frequently implanted device has been found to confer no benefit whatsoever over a much less invasive therapy. Cardiologists and radiologists often implant the device, called a retrievable inferior vena cava filter, inside people who are at high risk for developing potentially lethal blood clots. The filter is designed to prevent…

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American Heart Association Cancels Baltimore Conference

The American Heart Association announced last night the cancellation of a medical conference in Baltimore due to the unrest in the city. QCOR 2015, the Quality of Care and Outcomes Research Scientific Sessions, was scheduled to be held at the Hilton Baltimore from Wednesday to Friday this week. Here is part of what the AHA said: … Click here to…

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Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for…

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More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes

More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a…

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Inside The Scandal: Profit And Greed At An Embattled Laboratory Company

How does a clinical laboratory company grow in a few short years from nothing to more than $400 million in revenue and over $100 million in profit? Since the same company just settled with the DOJ for as much as $100 million, it’s reasonable to suspect that growth was probably not entirely legitimate. Now new information,…

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Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels….

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Heart Attack Risk Jumps After Divorce

A new study shows that after a divorce people have an increased lifetime risk for heart attacks (myocardial infarction). Although previous studies have found that MIs occur more frequently in people who are divorced, this is the first study to prospectively examine the lifetime relationship between divorce and MI. In a paper published in Circulation: Cardiovascular Quality and Outcomes, Duke…

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Weight Loss Programs: Slim Evidence And Poor Results

A new study concludes that some weight loss programs may be slightly better than other programs but that in the long run none of the programs have been able to show a substantial weight loss over a sustained period. For even the best programs, an editorialist writes, “weight loss is modest and likely below patients’…

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No, You Probably Won’t Drop Dead While Exercising

Dropping dead while exercising is a common fear, especially among middle-aged men. Unfortunately there have been limited data on the precise rate of sudden cardiac arrest (SCA) in middle-aged people and little understanding about the medical history of the victims of SCA. Now a new study fills in some important gaps in knowledge and shows that this fear…

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