Cardiology Is Dead. Long Live Public Health.

Cardiology is dead. Here’s two new important pieces of evidence:

1. The FDA’s Cardiovascular and Renal Drugs Advisory Committee hasn’t met since April 2015, and even then it was for the decidedly uninspiring drug cangrelor. And the committee has no meetings scheduled for the rest of this year.

2. Take a look at the list of late-breaking clinical trials for the American Heart Association’s Scientific Sessions in November in Anaheim. There are seven separate late-breaking sessions, but as far as I can tell not a single important or interesting late-breaking trial with significant consequences.

Original illustration by Max Husten

It should be acknowledged that even if the Cardiorenal committee has been frozen in time, like historical figures in a wax museum, the Circulatory System Devices Panel has been much more active. But the approval in recent years of a series of ineffective devices only highlights the desperation in cardiology to pretend that progress is still possible. As I’ve written in the past, the Watchman, Absorb, Impella and other devices have gained approval in recent years with absolutely no solid evidence demonstrating that their benefits outweigh their risks. And the promise of such evidence remains elusive and always seems to retreat further into the distance.

Bob Harrington is the current chairman of the Cardiorenal committee. He notes that “investment has shifted” from heart disease “to rare diseases and oncology. Perceived pathway to approval is easier and less expensive. And, pricing models for these drugs has been very different than for cardiovascular drugs.”

Milton Packer, who is also a member of the Cardiorenal committee, largely agrees with Harrington.“It is extraordinarily difficult for the pharmaceutical industry to make a serious investment in new cardiovascular drugs. Any new cardiovascular treatment necessarily competes in a marketplace that is dominated by generic drugs. As a result, third-party payers will allow pricing that is only marginally higher than a generic, or alternatively, they will allow for premium pricing but only if they can simultaneously create substantial administrative hurdles to discourage prescribing. Manufacturers need to choose a path, but they lose no matter which path they choose. They might choose a low-pricing strategy if they could be assured that the new drug would be rapidly adopted, but no guarantees are possible, because most patients with a cardiovascular disease are treated by generalists, not specialists, so adoption typically takes many years. So most companies sadly follow the path of premium pricing, hoping that practitioners will be willing to put in the hours needed to overcome preauthorization. But medical practices will simply not do that. As a result, pharmaceutical companies lose no matter which path they take. There is only one solution that remains: don’t develop cardiovascular drugs. Instead, develop drugs for oncology. That is exactly what they do, and it is precisely why no one is developing new cardiovascular drugs or devices. Who loses? Patients with cardiovascular disease.”

I don’t disagree with Harrington and Packer but I think there’s another way of looking at the situation. It is clear that for the most part any new advances, after the great achievements of the past (which include CABG, PCI, pacemakers, statins, ACE inhibitors, and blood thinners, for instance) will be modestly incremental, at best. We have reached the point of diminishing returns. The fact is that in cardiology the low hanging drug and device fruit has already been picked. “Most of the therapies are now generics so the bar is high to beat or add to successful, inexpensive therapies,” said Harrington.

Beyond Medicine

We  need to look beyond the traditional medical model of treating disease. Industry must decide for itself how to invest its resources. As a society, on the other hand, we need to take a far broader perspective. We need to ask how as a society we want to invest our resources. Major advances in cardiovascular health won’t come from medical progress. Progress now must take place in the sphere of public health.

This is why what was truly the biggest story at the recent ESC meeting  wasn’t a randomized controlled trial of a drug. Instead the really big story at ESC was PURE, an observational nutrition study. There’s a lot of disagreement about how to interpret PURE, and how knowledge from studies like this should be used to influence public policy, but can there be any doubt that if we want to make a really big impact it will have to be in the public health sphere?

There’s a wonderful story in the New York Times today about how cities in the Netherlands are investing millions in cycling infrastructure. Can there be any doubt that this is a better use for resources than spending ridiculous sums of money on monoclonal antibodies to lower cardio  vascular risk.   Why is it that as a society we have somehow decided— though of course no one explicitly decided this or voted on it— that we are willing and even eager to spend hundreds of thousands of dollars on people in the last months of their lives but are unwilling to provide funding for basic necessities in the early years of life?

It’s time to look at disease prevention not from a medical but from a public health point of view. If you don’t have established disease you shouldn’t be “treated” as a patient, you should be treated as a citizen or an individual human being.