INFLAMMATION AS THE CAUSE OF SICKNESS AND DISEASE
BRAND NEW STUDY PROVES THAT THE SCIENTIFIC
MEDICAL COMMUNITY IS TRYING TO SNOW YOU
The study (Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease), from the brand new issue of the New England Journal of Medicine, looked at just over 10,000 patients who had already had a heart attack and also had high levels of CRP and IL-6 --- common markers for inflammation --- and then gave them either a placebo or a drug called Canakinumab, intravenously, once a quarter, for four years. Not surprisingly (the study was funded by Novartis, manufacturer of Canakinumab) it led to "a significantly lower rate of recurrent cardiovascular events than placebo," without lowering CHOLESTEROL OR TRIGLYCERIDES. Because this study has been all over the news in recent days, we should discuss it just a bit.
The first thing I want to note is the excitement around this study. Why? Because the authors "proved" once and for all that inflammation is the cause of heart disease ("the inflammatory hypothesis of atherothrombosis had remained unproved"). While this many be technically true, it's not new information to my readers and it's certainly not new information the the medical community as a whole. All these researchers did was figure out another metabolic pathway of inflammation. That's it. That's all. Certainly cool, but not earth-shattering. Naturally however, in similar fashion to the way they discovered the COX II pathway of inflammation, work was immediately started to develop drugs to block it. And just like COX II Inhibitors, what did they find? They found SIDE EFFECTS.
Because inflammation is one of your body's many immune system responses, and because Canakinumab blocks inflammation, it stands to reason that this drug might be rough on the immune systems of those taking it. It was. The drug group had way more problems with infections than the placebo group. Some people might be willing to live with this if the drug really delivered on what's being claimed in all the PRESS RELEASES like that fact that other inflammatory diseases were positively affected by this drug as well. "significantly fewer reports of arthritis, gout, and osteoarthritis than did placebo. Cancer mortality was significantly lower with canakinumab than with placebo" (not surprising based on the first link in this post). But because the study of ANTI-INFLAMMATORY DRUGS is loaded with hype, hyperbole, and purposefully-created and overblown hope, let's dig a bit deeper.
Even though the study used the word "significant" numerous times in regards to results ('significant' is a mathematical word that has to do with the field of STATISTICS), an editorial in the same issue of the same journal by a Dr. Robert Harrington of Stanford, described the drugs as having, "modest absolute clinical benefit" (absolute benefit as opposed to relative benefit -- HERE). "Modest" is a way of saying that the drug worked, but not very much and not very well. This gets down to the ways that studies are set up and reported (HERE, HERE, and HERE). Even though this study reported that Canakinumab lowered incidence of second heart attacks by between 10 and 15%, it did not affect overall death rates ("All-cause mortality was neutral in the comparison of all canakinumab doses with placebo"). Health News Review put it like this...
"What does 15% translate to in absolute numbers? The way researchers measured results was in “events per 100 person-years”, and the “events” were non-fatal heart attack, non-fatal stroke, or death from a cardiovascular-related cause. In the placebo group, there were 4.50 cardiac events per 100 person-years. In the group receiving 150 mg doses of canakinumab, there were 3.86 events per 100 person years. Of the various doses given (50, 150 and 300 milligrams), the 150 mg dose was the only statistically significant result, and it was only because of non-fatal heart attacks."
And what must we pay for such "modest" clinical benefits --- benefits that do not involve improving overall mortality rates? In other words, how much does this drug cost? To go through a grand total of sixteen infusions of Canakinumab (four per year) over the course of forty eight months, the cost would be $800,000. I'm not making that up folks; eight hundred thousand dollars, or two hundred grand per year. To attempt to do something that can only done with diet and lifestyle. Listen to what Meghana Keshavan wrote a few days ago in STAT (Tantalizing Clues Point to Inflammation’s Role in an Array of Diseases. But Will Treatments Follow?), the medical news daily......
"Anti-inflammatory drugs have predictable and dangerous side effects, which showed up in the recent trial of the Novartis drug canakinumab in patients with cardiovascular disease. Some patients involved in the trial wound up becoming more susceptible to serious infections, such as the bacterial skin infection cellulitis, the deadly blood infection sepsis, and even tuberculosis. That’s because the body relies on inflammation to trigger the immune system to fight such invaders. Tamp it down too much and the immune system may not leap to your defense. “The problem is if you block inflammation, you’re blocking a primordial mechanism by which we are protected from the organisms that share the planet with us,” said Dr. Clay Semenkovich, chief of endocrinology, metabolism, and lipid research at Washington University in St. Louis."
We should not be surprised at this when you consider that SUPPRESSING THE IMMUNE SYSTEM is our medical community's number one way of dealing with these sorts of problems. If you look at other immunotherapy drugs --- drugs with names that end mostly in "mab" or "mub" --- you see similar long-term consequences of blocking immune system function. All of this begs the question of how you can ethically hype a drug that has such minimal benefits, such large potential side effects, and such a huge price tag? Ethically, you can't. But for BIG PHARMA, revving up the hype machine is easy; the same way it's been done for decades. Get the media to buy in and promote for you --- for free. A great example of this can be found in Harlan Krumholz' article for Forbes last week (Inflammation: Is It the New Cholesterol?). Krumholz wrote...
"Paul Ridker, the principal investigator of the CANTOS trial and a cardiologist at Harvard, is the leading proponent of this inflammation hypothesis. [Disclosure: Paul is married to my sister (and I want to disclose that) and so I have had a front row seat in these developments over the last two decades.] His work and that of other scientists carefully and methodically laid the groundwork for the idea that giving people treatment that would quiet their immune systems would reduce their risk of heart disease."
The question that Krumholz and others should be asking is why our collective immune systems are so ramped up in the first place that they would need quieted or suppressed (think AUTOIMMUNITY here)? Why have we become the INFLAMMATION NATION? And just as importantly, is the trajectory we are on with our current form of medical care sustainable? I have argued in the past that it is not (HERE). And just the other day, Dr. Suneel Dhand, guest-writing for the blog Kevin MD, agreed with me in his fun little offering called What Happens When the Healthcare Bubble Bursts? In his article, the good doctor gave us his Top-3 ways of solving this problem before the bottom completely falls out. The second two included, "Some type of single-payer system that accepts rationing.... Eliminating bureaucracy and administration...."
Not that I'm a fan of private health insurance (they are the evil empire), but a government-run system that eliminates bureaucracy is the very definition of an oxymoron (for those of you who actually pay your own health insurance, just look at the colossal amount of bureaucracy and cost added by the ACA). What must happen (but probably won't) is that people start taking charge of their own health and the health of their families. Chiming in with a response to Dhand's article, Cardiologist, Dr. Wade Martin agreed with this assessment.
Please see my letter to the editor on page 33 of the April 10, 2017 Barron's regarding the fact that the U.S. healthcare system is one of the greatest bubbles in world economic history with cardiology at the epicenter because of its incessant obsessive focus on coronary artery revascularization and cardiac imaging, which frequently do not improve mortality or prevent myocardial infarction. This, in one of the most sedentary, obese, opioid-addicted nations in world history with "private" sector healthcare costs twice those of any other developed country and the worst longevity of all of them. Tulips anyone?
This, folks, is the ugly truth about the unsustainability of American disease management that no longer has the right or privilege to be called healthcare (HERE). It's the MYTH OF EVIDENCE-BASED MEDICINE. The brutal truth is that Inflammation always leads to fibrosis / scar tissue (HERE), which just happens to be our nation's number one leading cause of death (HERE). This isn't really news in any sense of the word. If you are looking for a better way to deal with your inflammation than DANGEROUS AND EXPENSIVE DRUGS, make sure to at least read THIS SHORT ARTICLE I wrote on what it takes to get healthy and stay that way. Unfortunately, all bubbles eventually burst, and healthcare as you know it won't be around forever.