Fact Check: NY Times Heart Disease Series Gets It Right– Mostly 1

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. But be careful, because also abundantly evident are Kolata’s flaws.

For instance, here’s what she writes in the first story, about efforts to speed heart attack treatment:

Disparities that used to exist, with African-Americans, Hispanics and older people facing the slowest treatment times, have disappeared, Dr. Harlan Krumholz, a cardiologist at Yale, and his colleagues said in a paper in Archives of Internal Medicine.

But here’s what the Archives paper actually says:

Our analysis suggests that racial disparities in D2B times have significantly narrowed over time and that improving national quality of care appears to have not only improved overall performance but also diminished disparities.

Disparities that “have significantly narrowed” have not, obviously, “disappeared.” This is consistent with Kolata’s history, in which she takes a good fact-based story and transforms it into a great made-up story. (Most famously, Kolata did this in 1998 when she quoted James Watson— a quote which he later denied— predicting that researcher Judah Folkman was “going to cure cancer in two years.”) To be clear: this is only a minor point in an otherwise excellent story, but it would be unfortunate if readers of the story came away with the impression that treatment disparities are no longer a problem.

Even more disturbing problems crop up in her article on stents. Kolata claims that the 2007 COURAGE trial, which compared stents to optimal medical therapy, had little impact on medical practice:

Because of the doubts about that study and ingrained habits, medical practice was largely unchanged by its findings.

But this is simply wrong, and it is wrong about a key moment in recent medical history. Although COURAGE did not immediately change practice in a big way, it did provoke a great deal of heated discussion and soul-searching, and its overall effect has been long-lasting and profound. The principal investigator of COURAGE, William Boden, estimates that stent volume declined by about 20-25% from its pre-COURAGE peak in the mid 2000s. Quite simply, the trial ended an era of stent mania, and initiated in its place a medical culture much more likely to question unbridled enthusiasm for new drugs or devices.

In the same article on stents Kolata also makes a really basic error concerning patients with known heart disease. About one such patient she writes:

Like most heart patients, he had never taken the most important drug for those with his condition: a statin.

This is simply wrong. The vast majority of these patients– as many as 95%, according to one expert, Roger Blumenthal– are prescribed statins (if they are not already taking them) when they are diagnosed with heart disease. (Over time many discontinue the drugs but that is another issue entirely.)

I want to conclude with a discussion about a different sort of flaw in the first article on heart attack treatments. But first let’s be clear about its virtues. Kolata explains with illuminating details and quotes the behind-the-scenes efforts to shorten treatment times for heart attacks. In the past this story has been reported in only the most superficial manner. I’m sure many cardiologists and full-time observers of the scene like myself learned a great deal from this story. So Kolata deserves full credit for that.

But it’s also clear that Kolata fails to provide some important context for this story. For one, the article doesn’t touch on an even bigger and more intractable problem relating to the delivery of heart attack treatments: patient delays before seeking treatment. These delays are quite common. A short treatment time in the hospital won’t mean much if the patient waits several hours before calling 911 or showing up at the door. Knowing about this doesn’t diminish the significance of the achievement of reducing physician-related treatment delays as fully reported by Kolata, but it does add a wider perspective.

Similarly, Kolata writes that these reductions in treatment delay appear to have played a role in a 38% decline in deaths from heart disease over the past decade. But, again, she fails to place this decline in a larger context. The fact is that cardiovascular disease overall has been declining for more than 50 years. According to the CDC, heart disease deaths declined by 68% between 1960 and 2009, from 559 to 180 deaths per 100,000 people.  The precise reasons for the decline are unclear, though undoubtedly they involve broad lifestyle trends as well as major developments in the prevention and treatment of heart disease. Kolata’s readers would have benefited from knowing about this broader perspective.

So by all means go ahead and read the Kolata series. It’s good, really good. But it could be better.

 

 

 

 

 

 

Embattled Laboratory Files For Bankruptcy Reply

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 settlement with HDL which requires the company to make an initial payment of $47 million, though the final cost could be as high as $100 million.

The bankruptcy filing was a response to a notice of default sent to the company by its bank…

Click here to read the full post on Forbes.

 

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

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 measured with a handgrip dynamometer and were followed for roughly 4 years.

The results, published in the Lancet, show that grip strength is an even stronger predictor of death than systolic blood pressure…

Click here to read the full post on Forbes.

 

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

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 interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

Prominent Harvard Cardiologist Moves To Google X To Head Large Study Reply

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, where she will head up the much publicized Baseline Study.

“I’m jealous,” said one academic cardiologist at a top hospital, upon hearing the news.

Baseline is one of the ambitious projects undertaken by the life sciences division of Google X….

Click here to read the full post on Forbes.

 

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

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 of the drug beyond its current highly restricted FDA-approved indication (see reports in Forbes, the New York Times, and the Wall Street Journal.)

Click here to read the full post on Forbes.

 

 

Precision Medicine Approaches Peak Hype Reply

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 of improved health in the US over the next 50 years.

They used a health simulation model to estimate the effect of improved screening and risk prediction to treat people at high risk for 6 diseases: cancer, diabetes, heart disease, high blood pressure, lung disease, and stroke. They then calculated the resulting gains in life expectancy and quality-adjusted life expectancy.

They calculated that reducing heart disease by 50% “would generate a staggering $607 billion in improved health over 50 years.”

Click here to read the full post on Forbes.

 

Victor Dzau

Victor Dzau

 

 

 

 

 

 

 

 

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

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 have been no randomized trials in AF and only one trial, the famous DIG trial, in HF. In that trial digoxin had no impact on mortality but was found to help reduce the rate of hospitalization for HF.

Now researchers led by Stefan Hohnloser have performed a meta-analysis, published in the European Heart Journal, of 19 studies of digoxin, including more than 235,000 AF patients and 91,000 HF patients.

Click here to read the full post on Forbes.

 

Digoxin is derived from the foxglove plant (Digitalis lanata). (Photo by Oli Scarff/Getty Images)

More Evidence Linking Sugared Drinks To Diabetes 1

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 frequency questionnaire, as in most earlier studies…

Click here to read the full post on Forbes.

 

(Photo by Spencer Platt/Getty Images)

No Benefit For A Commonly Used Cardiac Device Reply

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 pulmonary embolism, an extremely dangerous condition that occurs when a blood clot from the legs migrates into the lungs. Now a new study published in JAMA shows that these devices provide no advantage over anticoagulant drugs which thin the blood.

Click here to read the full post on Forbes.

 

American Heart Association Cancels Baltimore Conference Reply

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 read the full post on Forbes.

 

 

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

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 heart failure in the sitagliptin group versus placebo.”

Click here to read the full post on Forbes.

 

More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes Reply

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 mortality benefit. But, the authors and other outside experts warn, the outcome findings should be interpreted with caution until long-term, dedicated outcome studies are completed.

Click here to read the full post on Forbes.

 

Amgen Door Hanger

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

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, gleaned from documents containing previously unreported details about the company, provides an inside look at the inner workings of the company and its rampant growth, fueled by greed and a massive disregard for law and industry standards. Except where otherwise indicated, the details of HDL’s finances reported below come from a financial statement and a spreadsheet prepared by the company and made available to me by a source. The details are consistent with information revealed by a former company employee with intimate knowledge of HDL’s finances.

Click here to read the full post on Forbes.

 

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Tonya Mallory, Former CEO and Co-Founder of Health Diagnostic Laboratory, Inc. in Richmond, Va. (PRNewsFoto/Health Diagnostic Laboratory, Inc.)

Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee Reply

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.

The two trials were the first large large cardiovascular outcomes trials of any diabetes drugs. SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals).

Click here to read the full post on Forbes.

 

Heart Attack Risk Jumps After Divorce Reply

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 OutcomesDuke University researchers analyzed data from a nationally representative cohort of 16,000 adults who were followed from 1992 to 2010.

Click here to read the full post on Forbes.

 

Weight Loss Programs: Slim Evidence And Poor Results Reply

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’ expectations.”

In a paper published in Annals of Internal Medicine, researchers report on an updated systematic review of studies evaluating weight loss programs…

Click here to read the full post on Forbes.

 

No, You Probably Won’t Drop Dead While Exercising Reply

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 is largely misplaced, given the small risk that exercise will lead to sudden cardiac death in most middle-aged people.

Click here to read the full post on Forbes.

 

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

 

Mark Cuban Should Take The Cigar Out Of His Mouth And Stop Giving Health Advice Reply

Last night the celebrity billionaire Mark Cuban ignited a firestorm on Twitter with the following recommendation to his 2.7 million followers:

1)If you can afford to have your blood tested for everything available, do it quarterly so you have a baseline of your own personal health

Led by ProPublica health reporter Charles Ornstein, a slew of doctors, health care experts, patient advocates and journalists tried to show Cuban the error of his ways.

Click here to read the full post on Forbes.

 

Cuban (large)

 

 

Global Cardiovascular Deaths Continue To Rise Despite Gains In Prevention And Treatment 1

Improvements in the treatment and prevention of cardiovascular disease haven’t been able to prevent a worldwide rise in cardiovascular deaths in a growing and aging population, according to the authors of a paper published in the New England Journal of Medicine. Using mortality data from the Global Burden of Disease Study 2013 the authors set out to “disentangle” the effects on cardiovascular mortality of population growth, an aging population, and epidemiological changes (defined as changes in risk factors and the effect of efforts to prevent and treat CV disease).

From 1990 to 2013 the total number of deaths caused by cardiovascular disease increased by 40%, from more than 12 million to more than 17 million a year.

Click here to read the full post on Forbes.

 

Doctors Halt Squabbling And Agree How To Manage Hypertension In People With Blocked Arteries Reply

There’s been a lot of drama in the hypertension field over the past few years. Initially sparked by the decision of the National Institutes of Health to end its sponsorship of national guidelines, the subsequent appearance of multiple guidelines with divergent recommendations led to even more controversy and discussion. Now, however, the appearance of a new scientific statement may indicate that some of the drama is dissipating, at least in one important subset of the field.

The scientific statement from the American Heart Association, the American College of Cardiology, and the American Society of Hypertension covers the important area of the treatment of hypertension in patients with existing coronary artery disease.

Click here to read the full post on Forbes.

 

No, An Apple A Day Won’t Keep The Doctor Away Reply

No, an apple a day does not appear to keep the doctor away. But, a new study semi-seriously suggests, it may keep the pharmacist away. The study serves as an instructive and humorous way to look at the perpetually thorny problem of how to best understand and make use of findings from observational studies. As this new paper makes clear, the limitations of observational studies are quite considerable, but that does not mean that they are completely worthless.

Although apples have long been considered a healthy snack, whether eating apples actually reduces healthcare use has not been assessed until now. In a paper published in JAMA Internal Medicine researchers examined the association between healthcare utilization and apple consumption in more than 8,000 adults participating in the National Health and Nutrition Examination Survey.

At first glance apples appeared to be related to significant benefits…

Click here to read the full post on Forbes.

 

Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs? Reply

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs may lead to significant reductions in heart attacks, stroke, and other cardiovascular events. But one finding, though not entirely new, has prompted a lot of discussion and concern.

Both studies reported a small but significant number of adverse neurocognitive effects in people taking the drugs. No one knows yet how important this finding will be, but it is clear that concerns about a real effect might have its own “adverse effect” on the drugs’ approval process.  Most experts seem to feel that they won’t be a very big problem, but none completely dismissed the issue either. Here are some of the main points under discussion:

Click here to read the full post on Forbes

 

 

 

New Cholesterol Drugs: Highly Effective But Important Questions Remain Reply

New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine.

The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully, which is what the drugs were designed to do. The situation is less clear regarding the more difficult to ascertain safety and tolerability of the drugs and their long-term clinical effects…

Click here to read the full post on Forbes.

 

 

PCSK9

Marc Sabatine presenting evolocumab results at the American College of Cardiology meeting in San Diego

 

 

Has CT Angiography Lived Up to Its Early Promise? Reply

When it first appeared more than a decade ago computed tomographic angiography (CTA) astounded cardiologists and other physicians. Until it came along the only way to check for blockages in the vital coronary arteries that supply the heart itself with blood was with cardiac catheterization, an expensive, highly invasive and unpleasant procedure. In the following years CTA (the devices are manufactured by GE, SiemensToshibaPhilips and others) enjoyed an explosion of growth, fueled by enthusiasm for its ability to deliver speedy, high-resolution images of the coronary arteries. Many anticipated that CTA would prove its worth and justify its expense and radiation dose. As explained by one cardiologist, Duke University’s Dan Mark, with CTA “only the patients who needed revascularization would actually go to the cath lab and the rest would avoid it,” leading to a reduced use of invasive tests, fewer unnecessary revascularizations, fewer false positives, and, therefore, significant economic advantages. Many years later, however, there is still little agreement about CTA and how it should be used in the diagnosis and management of people with chest pain.

Results of the NHLBI-supported Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE), presented at the American College of Cardiology meeting in San Diego and published simultaneously in the New England Journal of Medicine, provide the best evidence yet for the evaluation of CTA.

Click here to read the full post on Forbes.