How Many People Really Have Familial Hypercholesterolemia– And Does It Matter?

A new study estimates that about 834,000 adults in the US have genetically high cholesterol levels, otherwise known as familial hypercholesterolemia (FH). The prevalence of FH, which the authors calculate as 1 in 250 American adults, is twice the size of earlier assumptions. But the authors acknowledge that the criteria for FH used in their…

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Studies Spotlight Role Of Triglycerides, Put HDL In The Background

Two new studies provide more evidence tilting the balance in favor of triglycerides rather than HDL playing a causative role in cardiovascular disease. But it is still too early to know whether the findings of any of the studies will point to useful new methods to prevent and treat disease. In the first study, published…

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The Door Opens Wider For Drug Companies To Make Off-Label Claims

The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA.  The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…

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Theranos Ignored Red Flags On Its Blood Clot Tests

Beleaguered laboratory company Theranos sent out unreliable blood clot tests on at least 81 patients, according to an article by John Carreyrou and Christopher Weaver in the Wall Street Journal. Theranos, a former darling of Wall Street, Silicon Valley, and high technology medicine enthusiasts, has been the subject of a series of embarrassing revelations in…

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Controversial, Ill-Fated Obesity Drug Trial Published In JAMA

The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…

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Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial

Novo Nordisk today announced top-line positive results of the LEADERS trial, the cardiovascular outcomes trial testing its diabetes drug Victoza (liraglutide). Liraglutide is a GLP-1 inhibitor used to help achieve glucose control in patients with type 2 diabetes. 9,340 people with type 2 diabetes were randomized to liraglutide or placebo in LEADERS for 3.5 –…

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Large Genetic Studies Support Role For Triglycerides In Cardiovascular Disease

Two  papers published in the New England Journal of Medicine offer new genetic evidence to support the increasingly accepted though still controversial view that triglycerides play an important causal role in cardiovascular disease. If fully validated the new findings could lead to new drugs to prevent and treat cardiovascular disease, though others caution that there…

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Best Selling Smartphone Blood Pressure App Gave Wrong Results

A best-selling smartphone app that purported to measure blood pressure actually delivered highly inaccurate results, according to a research letter in JAMA Internal Medicine.  The finding could cause genuine medical harm for the large number of people who use the app. In addition, the study adds new fuel to the fiery debate about the reliability…

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Shedding Light On The Hearts Of Pro Basketball Players

Every time an athlete dies on the field there is renewed interest in the controversial topic of preparticipation screening. One key limitation in the field is that there is little or no good data about what constitutes a healthy heart in athletes. Now a new study published in JAMA Cardiology provides an extraordinarily detailed look…

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At the FDA Rob Califf Will Champion Clinical Trials

Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda. Or, as one reporter tweeted: Hey, is that the sound of the FDA approving things faster? Must be because the Senate…

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Vulnerable Plaque: The Paradigm That Failed

Is it a hallowed paradigm or a hype-othesis? The “holy grail” of cardiology is to stop heart attacks before they happen by identifying– quickly, noninvasively, and specifically– those coronary artery lesions that result in heart attacks. The key theoretical underpinning driving this goal has been the vulnerable plaque hypothesis, which holds that the vast majority…

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Slow Down. Don’t Sprint To More Aggressive BP Treatment

Two editorialists in Annals of Internal Medicine urge caution in interpreting and adopting the findings of the SPRINT (Systolic Blood Pressure Intervention Trial), which last year  showed a benefit for a more aggressive approach to blood pressure therapy. The trial found improved outcomes in  high risk patients treated to a target of of 120 mm…

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FDA Turns Down Expanded Indication For Zetia And Vytorin

The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck).  This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for…

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Study Finds No Improvement In Quality Of Life With ESAs

Erythropoietin-stimulating agents (ESAs) continue to be widely prescribed despite the absence of evidence demonstrating benefit. TREAT– the first and only large trial to test clinical outcomes with the drugs–showed that ESAs did not reduce clinical events, though it did raise concerns that the drugs might increase the risk of stroke. Critics say that the drugs…

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US Freezes Millions Of Dollars In Assets Of Rogue Lab Sales Force

The US government is freezing millions in dollars in assets from the owners of BlueWave, the sales company that participated in “a massive kickback scheme” involving Health Diagnostics Laboratory (HDL) and a second smaller laboratory company, Singulex, Inc. A US judge last week granted an application from US and state attorneys to ensure that BlueWave…

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Vampire Lab Turns To Old Trick To Grow Business: Physician Owned Labs

(Updated) True Health Diagnostics, the new laboratory that bought the assets and adopted the business model of the disgraced and bankrupt laboratory company Health Diagnostic Laboratory (HDL), is turning to some old, unethical, and illegal tricks to grow its business. As I’ve reported previously, one key to the spectacular growth of HDL laboratory involved surreptitious…

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Deals Seek To Link Entresto Cost To Effectiveness

For two large insurance companies payment for the new heart failure drug Entresto will be linked to its health benefits. Both Cigna and Aetna have confirmed that they have reached a pay-for-performance deal with the drug’s manufacturer, Novartis. According to  a press release issued by Cigna, “the pay-for-performance agreement ties the financial terms to how…

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The Real Losers In The Zombie Versus Vampire Lab Company Court Battle

(Updated) Right now a dead, bankrupt and corrupt laboratory company is suing an active, morally bankrupt lab company. No matter who eventually wins the court battle all of us– patients, Medicare, insurance companies, not to mention our entire health and legal systems– will lose. Health Diagnostics Laboratory (HDL) is the zombie lab company. After raking…

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FDA Announces Sweeping Changes In Approach To Opioid Drugs

The FDA announced today that it planned sweeping changes in its approach to opioids drugs. The move comes in response to growing concerns over abuse of prescription opioids in the US and escalating criticism of the FDA’s lackluster response to the problem. Two US Senators have said they would oppose President Obama’s nomination of Robert…

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New Studies Seek To Allay Concerns Over The ROCKET-AF Trial

New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…

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Entresto Maker In Deep Water Over Terrifying TV Advertisement

Updated with comments from Novartis and Mary Knudson– A Novartis television commercial and advertising campaign is terrifying millions of people and provoking sharp criticism from doctors. The critics include Milton Packer, a top expert who ran the main trial testing the company’s big new heart failure drug, Entresto. The ad depicts a middle-aged man in…

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Slow Start For ‘Blockbuster’ Heart Failure Drug Entresto

Entresto, the new heart failure drug from Novartis that is widely expected to be a blockbuster, is off to an exceptionally slow start. Approved last July, the drug, formerly known as LCZ 696, had sales of only $21 million in 2015, only $5 million of which came in the fourth quarter. Despite low expectations in the early…

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A Lab Industry Veteran Deciphers The Zombie Lab Enigma

True Health Diagnostics (THD) is the new, rapidly growing lab that bought the assets of the disgraced and bankrupt Health Diagnostic Lab (HDL). (See the bottom of this story for links to my previous coverage of this story.) I asked one industry veteran for his thoughts on THD’s business practices and the relationship between THD…

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NEJM Editor Flip Flops On Data Sharing After Social Media Firestorm

After a firestorm of criticism on social media over his editorial comments,  Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, is trying to quiet a growing controversy by modifying his position regarding shared data. The firestorm was ignited by an editorial on data sharing in last week’s NEJM. Although highly supportive of…

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Four Senators Now Oppose Califf Nomination To Head The FDA

(Updated on January 26 and January 27) US Senator Edward Markey, a Democrat from Massachusetts, is seeking to block Rob Califf’s nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination. In September President Obama nominated Califf, a well-known Duke…

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