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.

 

 

 

 

 

 

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Can You Test A Drug And Also Say Negative Things About It? 8

In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to consider important distinctions and subtleties in the academic literature about conflict of interest.

Let me first of all confess that Stein– for whom I have the highest possible regard– makes some excellent points. And I further admit that my piece pretty much ignored some of these fine academic distinctions. But I also think it’s likely that we may have a forest and trees situation here and that by focusing on subtle COI distinctions it is possible to lose sight of the larger issue.

A Simple Test

Rather than focus on the subtle distinctions between different types of COI I’d like to propose a much simpler way to think about this problem as it exists in the real world. Here’s the test I would propose: can you imagine Nissen, or indeed anyone in a similar situation (running a large multimillion dollar trial of a drug) publicly saying something decidedly negative or critical about the drug?

Click here to continue reading…

Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs 6

(Updated)

Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem?

This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron.

Nissen was broadly supportive of the drugs. Although he has been one of the leading voices against approving and using drugs based solely on their effect on surrogate outcomes, he was much more liberal about these drugs than some other experts and many of the panel members. Here’s what he told CNBC:

“I am somebody who generally is opposed to approving drugs on the basis of surrogate endpoints without the outcome data,” Nissen said by telephone Wednesday, referring to lowering of LDL cholesterol already shown by the medicine. “However, in this case, I actually support approval and I actually think the concerns of the committee are not on target.”

On the NBC Nightly News program he was even more effusive:

“These drugs are breakthrough drugs, they are blockbuster drugs that are very likely going to have a big impact.”

Click here to continue reading…

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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Another One Bites The Dust: On The Death Of A Social Media Site For Doctors Reply

Like a certain late lamented parrot, CardioExchange is no more. It has ceased to be.

The website was started by the New England Journal of Medicine and the Massachusetts Medical Society more than 5 years ago in the wake of the explosive and ubiquitous growth of social media. But the rise of social media also provoked tremendous uncertainty and even anxiety over its role in healthcare and medicine. In response to this major transformation of the media landscape, MMS and NEJM launched CardioExchange as an experiment in social media for cardiologists and other healthcare professionals interested in cardiovascular medicine.

Click here to read the full post on Forbes.