The headline in the New York Times (NYT) this morning–8.28.2017– states, “Anti-Inflammatory Drug May Lower Risk of Heart Disease and Cancer. Findings Represent Medical Milestone.”
I am getting tired of using the “Fake News” meme when describing medical articles in the NYTs. But, this article is beyond ridiculous and I can think of no better way to describe it. This is another example of fake news and why we are in the health care mess we are in.
My wife, Allison, showed me the NYT article this morning. I glanced at the headline and said to her, “There is no way that way-too-expensive drug will lower the risk of heart disease or cancer because of its mechanism of action.” I told her I was going to pull the original New England Journal of Medicine (NEJM) article (http://www.nejm.org/doi/full/10.1056/NEJMoa1707914?query=featured_home) and do the statistics on my own.
Here’s my analysis of this “medical milestone”.
This was a randomized, double-blind trial of Canakinumab (brand name Ilaris), a drug that poisons interleukin-1β (IL1β). IL1β is produced by the white blood cells and is involved in a variety of cellular processes including producing fever. Fever is the body’s response to an infection. The body increases its temperature in order to kill pathogens that have infected it. IL1β is also associated with other cellular functions including cell proliferation, differentiation and apoptosis—programmed cell death.
Inflammation is a normal response of the body to injury, trauma, or infection. Signs of inflammation—redness, warmth, pain, and swelling–are common. Inflammation is stimulated by the inflammatory cascade which includes molecules like IL1β. IL1β and other inflammatory molecules are not bad actors,0 rather they are much-needed molecules used to help the body heal from an inflammatory insult. In the case of a fever due to an infection, the elevated temperature is there to help the body kill the bacterium or virus and to also stimulate other immune system cells to come to the aid. In the case of an ankle sprain, the swelling, redness and warmth around the ankle serves the purpose to recruit other immune system cells to the area to remove the injured tissue so that new tissue can take its place. Without the inflammatory response, the body would never heal from an injury.
Why would you want to take a medication for the long-term that inhibits the healing reactions of the body?
Although commonly used anti-inflammatory medications such as aspirin, Motrin or Tylenol, can reduce fever and pain, there are many studies that the long-term use of anti-inflammatory medications acutally slows the healing process and can lead to other serious problems. IF there is an inflammatory problem in the body, the doctor should actively search for what is causing the inflammation in the first place and treat that.
There is no reason to doubt that anti-inflammatory medications like Ilaris would result in adverse effects. To disrupt a crucial part of the inflammatory cascade that is responsible for apoptosis would lead any thinking physician to believe that this would increase one’s risk for cancer the longer the medication is taken.
Let’s go back to the NEJM study. The authors primary endpoint of the study was the difference between the treated group and the placebo group in the numbers of nonfatal heart attacks, nonfatal strokes, or cardiovascular deaths after 48 months. In the placebo group, 16% suffered one of the primary endpoints. For those that took the drug,[i] 14.2% suffered a primary endpoint. My analysis found a 12% relative risk reduction for subjects who took Ilaris compared to those who took a placebo. But, as I have stated many times before, the relative risk is a statistical tool used by The Big Pharma Cartel to make a poorly performing drug look better than it actually is. In fact, relative risk reduction should never be used when considering whether to use a drug or not. The absolute risk difference between the two groups is 1.8% (16% – 14.2%). I explain more about these statistical manipulations in my book, The Statin Disaster.
That means Ilaris failed 98.8% (100%-1.8%) of those who took it.
That is a medical milestone?
Folks, that is the perfect example of “Fake News” at its best.
Not only did the drug fail most who took it, those who took Ilaris were found to have a higher incidence of fatal infection compared to those who took placebo. That should easily be predicted knowing the mechanism of action of this drug.
As for the sub-headline about reducing the risk of cancer, this study was not designed for that purpose. It was found to reduce the number of deaths from lung cancer. However, that number was miniscule and there were too few patients who actually died of lung cancer to make any firm conclusion.
This drug costs approximately $200,000 per year. Of course, the sponsor of the study, Norvartis produces Ilaris. And, the lead author of the study has a conflict-of-interest with the C-reactive protein test that was used in the study. As for the rest of the conflicts of interest, I lost interest as there were too many to report here.
I will now use these NEJM and NYT articles as a teaching tool for medical students. I will teach the students how to identify fake news and how to properly dissect research articles in order to decide if a drug should be prescribed for a particular patient. More information about the problems with drug therapies can be found in my book, “Drugs That Don’t Work and Natural Therapies That Do.”
Ilaris for preventing or treating heart disease?
DrB[i] There were different doses of Ilaris given. For brevity, I have summarized the data for all the doses given.