Califf To Leave Duke To Become FDA Deputy Commissioner Reply

The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.”

Click here to read the full post on Forbes.

 

Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race Reply

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA) for alirocumab, their PCSK9 inhibitor…

Click here to read the full post on Forbes.

 

Salt, Science, And The American Heart Association’s Double Standard Reply

Once again the American Heart Association is sticking by its recommendation that pretty much everyone should consume no more than 1,500 milligrams of sodium each day. This is dramatically lower than the 3,500 mg/d the average American now consumes. In a blog post reprinted on MedPage Today the president of the American Heart Association,  Elliott Antman, assails a study published earlier this week which found no benefits– and even a hint of harm–  for elderly people with low sodium consumption.

But Antman only tells one side of the story.

Click here to read the full post on Forbes.

 

Why Doctors, Like Airline Pilots, Should Not Be Completely Trusted.  Reply

I would never get on an airplane if I didn’t feel highly confident that the pilot was fully competent. In order to fly a commercial airplane a pilot has to  undergo rigorous and continuous training and testing. I’d walk before flying with a pilot whose only credential was his assurance that he’d been diligently “keeping up with his field” and that he was extremely confident in his abilities. I’m glad to know that the FAA and the airlines have extremely demanding programs to ensure the competency of pilots.

I would trust 99% of pilots to remain competent on their own. But when it comes to flying 99%” isn’t good enough. We need to know, within the bounds of what is reasonable, that all pilots are competent. Unfortunately, because of the few bad ones, the remaining 99% have to undergo all the rigorous training and tests.

Doctors are like pilots: what they do is far too important to let them individually decide for themselves whether they are competent, or how they should demonstrate their competency. Just because the vast majority of pilots and doctors are competent doesn’t mean that we should loosen our standards.

This topic is important now because of a current red-hot debate over what physicians have to do during their career to maintain their certification– called maintenance of certification, or MOC…

Click here to read the full post on Forbes.

 

Buried Clinical Trial Data: The Dam Is About to Burst Reply

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials.

… a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial.

… the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data.

Click here to read the full post on Forbes.

 

AstraZeneca Drug Improves Outcomes After Heart Attacks Reply

For the first time a very large trial has shown that dual antiplatelet therapy (DAPT) improves cardiovascular outcomes when given to patients one to three years after a heart attack. Because it has been shown previously to reduce the high risk of recurrent events for up to a year following a heart attack, DAPT is considered to be standard therapy during this time period. But whether or not longer term treatment after a year would be also beneficial has been controversial.

AstraZeneca  today announced that the Pegasus-TIMI 54 study had successfully reached its primary endpoint.

Click here to read the full post on Forbes.

 

More Turmoil For Troubled Medical Laboratory Company Reply

Problems continue to accumulate for the deeply troubled medical laboratory company Health Diagnostic Laboratory. Following several years of spectacular growth, in which the company grew to $400 million in annual revenue, the company last year began an equally spectacular implosion when it became known that the federal government was investigating the company for giving kickbacks to physicians to use the company’s tests. Additional allegations suggested a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

In the latest development HDL terminated its contract with BlueWave Healthcare Consultants, the sales company that played a crucial role in HDL’s explosive growth. In response BlueWave filed a lawsuit against HDL for $205 million…

Click here to read the full post on Forbes.

 

Three Reasons Why You Don’t Need To Feel Sorry For Doctors Reply

I’m not a doctor and I don’t have strong opinions about how doctors should be certified or, more to the point right now, what they should have to do to maintain their certification over the course of their careers. But recently this last topic– called maintenance of certification, or MOC– has become the subject of a raging debate within the medical community, as thousands of doctors have expressed their displeasure, to put it mildly, with a new recertification scheme established last year by the American Board of Internal Medicine, the official “certifying” body of a large proportion of doctors in the US. From what I’ve read it appears that the critics of the new system have some very legitimate points and that some big changes will likely be necessary. But in the course of the debate I have been disturbed by some of the arguments that have been used to criticize the new MOC. (Unfortunately I haven’t seen a lot of attempts to actually defend the new scheme so I can’t give equal time to the other viewpoint.)

Click here to read the full post on Forbes.

 

FDA Approves New Oral Anticoagulant From Daiichi Sankyo 1

And then there were four.

Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace…

Click here to read the full post on Forbes, including a comment from Sanjay Kaul.

 

An Emerging Consensus About Novartis’s New Potential Blockbuster Reply

Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in cardiovascular mortality, electrified the cardiovascular community. But the trial also sparked a lot of controversy when skeptics raised questions suggesting that the results were not nearly as impressive as the investigators reported.

Following the initial excitement and discussion we are now starting to get a more measured and realistic view of the drug and the trial. In recent days two important secondary PARADIGM papers have been published. A paper in Circulation looks at the experience of trial participants who didn’t die. A paper in European Heart Journal performs some sophisticated statistical wizardry to estimate how LCZ696 would have performed against placebo instead of an active comparator. It will probably come as no surprise that both papers are highly positive. The Circulation paper shows that LCZ696 was effective in preventing progression of heart failure. The EHJ paper concludes that if it had been compared to placebo in a contemporary, otherwise well-treated population LCZ696 would have produced “striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization.”

Far more important than these papers, in my view, are the accompanying editorials. The Circulation editorialist, Henry Krum, is an influential Australian cardiologist and the EHJ editorialist, Duke University cardiologist Rob Califf, is one of the most influential and respected cardiologists in the world…

Click here to read the full post on Forbes.

 

2014 Dubious Innovations In Cardiology Reply

 

  • Dubious Innovative Device: Renal Denervation
  • Dubious Innovative Business Strategy: Health Diagnostics Laboratory
  • Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine
  • Dubious Innovative Breakthrough Therapy That Never Actually Breaks Through Anything (repeat winner): Cardiac Stem Cell Therapy

 

Click here to read the full post on Forbes.

 

 

European Review Confirms Increased Risk with Ivabradine Reply

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug is not available in the U.S. but is under development by Amgen for the indication of heart failure.

Click here to read the full post on Forbes.

 

 

 

Intent To Tweet And A Failure Of Communication Reply

For more than 15 years I’ve been trying to figure out how physicians can get involved with social media without devolving into Beliebers. It’s not easy. I often joke that the job is a bit like being the social director on a cruise for people with Asperger’s. But here’s the twist: it’s easy to be the social director on a cruise for sorority sisters and fraternity brothers, but you’re not really going to bring anything to the party that they won’t bring themselves. By contrast, those Asperger’s cruisers, just like many doctors, really need help making good use of social media.

A new study published in the venerable medical journal Circulation is a great example of the problems traditional medicine is having trying to figure out social media….

Click here to read the entire post on Forbes.

 

IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe Reply

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo or that LDL might not be a reliable surrogate endpoint. The IMPROVE-IT results will also provide comfort to companies developing the next generation of cholesterol drugs, since their approval may have depended on validation of LDL as a surrogate endpoint.

The  Improved Reduction of Outcomes: Vytorin Efficacy International Trial, presented Monday morning at the American Heart Association meeting in Chicago, randomized 18,144 high-risk patients within 10 days of an acute coronary event to either ezetimibe or placebo on top of a statin….

Click here to read the full post on Forbes.

Cannon

At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs 1

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the McCormick convention center.

Click here to read the full post on Forbes.

Amgen Door Hanger

 

IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine 1

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications.

Click here to read the full post on Forbes.

 

What You Need To Know About IMPROVE-IT Reply

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing the end of its patent life the commercial significance is somewhat limited. However, IMPROVE-IT will also have very important implications beyond its specific effect on one drug franchise and could influence the fate of several new drugs now being investigated and may even alter the entire drug development and evaluation process.

Here’s some background information and links to useful resources.

Click here to read the full post on Forbes.

 

Grad Student Invents Flying Ambulance Drone To Deliver Emergency Shocks Reply

Drones have been used to kill people in war zones and to spy on people. Now a sharp young  graduate student in the Netherlands has come up with an innovative new use for drones that could one day help save thousands of lives.

Click here to read the full post on Forbes.

[youtubevid id=”y-rEI4bezWc”]

 

 

 

Ebola, Natural Cures, And Panic: A Rant Reply

I try to stick to writing about cardiovascular topics but it’s been hard to avoid thinking about ebola in recent weeks. Trying to take a break from the ebola insanity yesterday I turned to Facebook to find some cute cat videos. Instead, I found this, posted by an old friend, from the Organic Consumers Association:

There are natural methods proven to be effective for prevention and treatment of Ebola. But doctors refuse to explore them.

My friend simply asked her FB friends: “What do you think? Please share.”

I’m afraid I didn’t respond well:

Click here to read the full post on Forbes.

Organic Ebola FB

`

Paper Behind The Green Coffee Bean Diet Craze Retracted Reply

The “scientific” paper that helped ignite the green coffee bean diet craze has been retracted. The details of the retraction and the full background of the story were fully reported by Ivan Oransky on Retraction Watch.

The paper, published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, purported to report the substantial weight loss findings of a randomized, double-blind, placebo-controlled crossover study of green coffee bean extract. The article has been viewed or downloaded by more than three-quarters of a million people since its publication in January 2012.

Click here to read the full post on Forbes.

 

English: Photo of Dr.Oz at the Time 100 Gala.

English: Photo of Dr.Oz at the Time 100 Gala. (Photo credit: Wikipedia)

 

Cigna Sues Embattled HDL Laboratory For $84 Million Reply

The Cigna Health and Life Insurance company is suing Health Diagnostic Laboratory Inc. for $84 million.  As reported previously, the embattled lab company is the subject of an ongoing Federal investigation concerning kickbacks and fraudulent billing.

The charges against HDL in the suit filed last week in federal court closely echo the earlier allegations against the company.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack! Reply

Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.

“Your test results are giving me a heart attack!”

Click here to read the full post on Forbes.

 

Inappropriate Heart Stress Tests May Waste Half A Billion Dollars A Year Reply

Inappropriate cardiac stress tests may cost the US healthcare system as much as half a billion dollars each year, according to a new study published in Annals of Internal Medcine.

Click here to read the full post on Forbes.

 

Nuclear medicine myocardial perfusion scan wit...

Nuclear medicine myocardial perfusion scan with Thallium-201 for the rest images (bottom rows) and Tc-Sestamibi for the stress images (top rows). The nuclear medicine myocardial perfusion scan plays a pivotal role in the noninvasive evaluation of coronary artery disease. The study not only identifies patients with coronary artery disease, it also provides overall prognostic information or overall risk of adverse cardiac events for the patient. (Photo credit: Wikipedia)