Clinical trial yields tantalizing heart and cancer clues

Dr. Jose Rivera, a cardiologist with the Steward Health Group and the Sebastian River Medical Center, is finally getting some high-powered validation for his long-held view that reducing inflammation – not just cholesterol levels – can prevent heart attacks.

As Time Magazine reports, “In a new paper published in the New England Journal of Medicine and presented at the European Society of Cardiology meeting, scientists say they now have proof that lowering inflammation alone, without affecting cholesterol, reduces the risk of a heart attack.”

The Washington Post and the New York Times both ran front-page articles about the study.

The Post quoted David Goff, director of the division of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, as saying this clinical trial “has opened up a potent way to lower the risk of heart attacks.”

The Times went further, calling the study “a major milestone” and “proof of a biologic concept that opens the door to new ways of treating and preventing cardiovascular disease.”

At the center of the massive study – 10,000 patients from 39 countries – is the Novartis drug “Canakinumab.”

Rivera says the drug “binds this pro-inflammatory protein called Interleukin-1 beta that triggers a cascade of inflammation.”

But don’t rush to Rivera or any other cardiologist looking for a prescription just yet. The drug is not approved by the FDA for use in cardio cases and probably won’t be any time in the near future.

That’s because Canakinumab also suppresses part of the immune system, increasing the risk of infections – including fatal ones.

In fact, the Times reports, “deaths from infection in the study appeared to match lives saved by the drug, so there was no difference in overall mortality between the groups that got the drug and [those who got] the placebo.”

So is that game, set and match? Is it the end of Canakinumab.

Not likely.

The New England Journal of Medicine offers another Canakinumab bombshell that will likely make it impossible to stop further work on the drug.

It reports that a separate study published in the prestigious British medical journal “The Lancet” found people taking Canakinumab lowered their risk of dying from any type of cancer over four years by a startling 50 percent and their risk of fatal lung cancer by a mind-boggling 75 percent.

This wouldn’t be the first time a drug developed for one purpose explodes into a blockbuster cure for something else entirely.

In the 1990s, Pfizer was trying to develop a new drug for angina. In clinical trials, it seemed only modestly effective but as Medpagetoday.com puts it, “researchers found that men taking the drug experienced an unexpected side effect. Their sexual performance improved dramatically. Soon no one at Pfizer cared about the [drug’s] effect on chest pain. The company only cared about the side effect. Today we call that drug ‘Viagra.’”

This type of story is commonplace in drug development. In the search for ‘X’ drug developers sometimes find ‘Y.’”

Meanwhile, the current projected price for Canakinumab is somewhere between $64,000 and $200,000 a year (assuming it ever gets FDA approval in its current formulation).

That would be quite pricey as a cardio drug, but it would be a bargain-basement cost when compared to some cancer drugs on the market today – especially if that 75 percent rate of avoiding fatal lung cancers holds up, let alone the 50 percent rate of avoiding all cancers altogether.

Possibly overstating the obvious, Rivera smiles and says, “It’s going to need more research,” but this particular cardiologist is clearly optimistic.

“I think that this is, again, a great story because it gives us a lot of information in terms of validation [and] confirmation on inflammation. How important inflammation is after atherosclerotic disease or cardiovascular events,” not to mention the further study-worthy impact it may have on cancer treatments.

In the meantime, Rivera plans to continue helping his patients reduce both their cholesterol levels and their inflammation levels with simple, already well-proven steps. Those may include statins, exercise and diet as well as monitoring “C-reactive proteins” with CRP blood tests that can spot potential inflammation problems before they lead to heart attacks.

 

Dr. Jose Rivera is with the Steward Health Group and the Sebastian River Medical Center. His offices are at 7754 Bay Street in Sebastian. The phone number is 772-589-3003.

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