Doctor Scorecards: The Wrong Answer To The Right Question 1

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 except to say that I think you’d have to be crazy to rely on the Scorecard as a deciding factor to use in the choice of a surgeon, but that it could be helpful when used cautiously and with other decision aids.

What I want to consider here is a somewhat different question, which relates to the idea of a scorecard. Now the ProPublica reporters went to great efforts to put their scorecard into perspective and to explain its limitations, but it remains a scorecard, which is a simple measure of something that is in reality extraordinarily complex.

I want to argue that the very concept of a scorecard represents the wrong way to think about the problems that the scorecard attempts to begin to address.

Click here to read the full post on Forbes.

 

Novartis Heart Failure Drug Gains Speedy FDA Approval Reply

Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived 6 weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.Novartis said the wholesale acquisition cost of Entresto will be $12.50 per day, less discounts.

According to Novartis, the label will state that Entresto is “indicated to reduce the risk of cardiovascular death and heart failure hospitalization in patients with chronic heart failure (NYHA class II-IV) and reduced ejection fraction. Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.”

Entresto is the first of a new class of drugs known as Angiotensin Receptor Neprilysin Inhibitors, or ARNIs. It consists of the well-known angiotensin receptor blocker valsartan and a novel compound, the neprilysin inhibitor sacubitiril. Inhibition of neprilysin is intended to held reduce the neurohormonal activation that helps drive common heart failure (HF) processes like vasoconstriction, sodium retention, and remodeling. This specific combination was designed to avoid angioedema, a side effect which doomed a similar earlier drug, omapatrilat, which combined an ACE inhibitor and a neprilysin inhibitor.

The drug will be available in three dosage strengths: 24/26 mg, 49/51 mg and 97/103 mg (sacubitril/valsartan). The label recommends that most patients should start with the middle dose and move to the higher dose after 2-4 weeks. The lower dose may be preferred for some patients.

Excitement about Entresto began last year following the impressive results of the PARADIGM pivotal trial, in which 8,442 HF patients with reduced ejection fraction (EF) were randomized to the ACE inhibitor enalapril or Entresto. As I’ve reported previously, the study was stopped early, though enrollment in the trial had been completed, following an interim analysis performed by the data and safety monitoring committee, which found “that the prespecified stopping boundary for an overwhelming benefit had been crossed.” After a mean followup of 27 months, Entresto was superior to enalapril in most of the major outcomes. There were significant reductions in the primary endpoint (the combination of cardiovascular death or hospitalization for HF), the individual components of the endpoint, all-cause mortality, and HF symptoms.

Entresto is the first HF drug that has been shown to have a significant mortality benefit when compared to an ACE inhibitor, the current standard of treatment.

The FDA said the most common side effects in patients receiving Entresto were hypotension, hyperkalemia, and renal impairment. Black patients and patients with a history of angioedema are more likely to develop angioedema. In PARADIGM angioedema occurred in 19 Entresto patients and 10 enalapril patients. Entresto should not be used while patients are also taking an ACE inhibitor as this increases the risk of angioedema.

Although there have been previous concerns that Entresto might increase the risk of developing dementiaNovartis said there is no mention of dementia in the label.

“Despite the uncertainty and high financial risk we designed the world’s largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” said David Epstein, Division Head, Novartis Pharmaceuticals, in a press release. “We recognize our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week.”

“The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA. “Entresto is expected to change the management of patients with HFrEF for years to come.”

ENT_US_TM_PROM_4CP_FC_POS_Beta

 

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.

 

 

 

 

 

 

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.

 

Previous Stories About HDL:

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.

 

Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel Reply

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain.

FDA approval of Entresto is expected to occur by August at the latest. There are no apparent roadblocks to approval since Novartis has stated that it doesn’t expect an FDA advisory panel. Approval might well come earlier this summer.

At the ESC heart failure meeting this weekend Entresto investigators will also deliver some supporting secondary information about the drug….

Click here to read the full post on Forbes.

 

No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize 1

Let’s start with a quick poll:

 Which is worse?

  • A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians.
  • B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights.

If you chose B then you are going to really love Lisa Rosenbaum’s 3-part series in the New England Journal of Medicine in which she argues that the reaction against the influence of industry has proved to be far worse than any damages those conflicts of interest (COI) have actually produced.

I think Rosenbaum is almost completely mistaken in her views…

Click here to read the full post on Forbes.

 

 

Screen Shot 2015-05-20 at 7.41.59 PM

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.

 

Previous Stories About HDL:

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

Medicines Company Drug Finally Gets Nod From FDA Advisory Panel Reply

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.

Click here to read the full post on Forbes.

 

FDA Approves Amgen Heart Failure Drug Reply

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan.

Ivabradine was approved for the reduction of hospitalization from worsening heart failure.

Click here to read the full post on Forbes.

Corlanor logo