Sunday, December 2, 2018

The Risks of Drug Side Effects - A Case for Caution and Humility


I prescribe heartburn medicines every day.   There’s a gaggle of them now – Prilosec, Nexium, Prevacid, Protonix – to name a few.  As far as experts know, their primary effect is to reduce the production of stomach acid.  This is why they are so effective at putting out your heartburn fire.  In simple terms: no acid, no heartburn.

I am quite sure that well-meaning physicians like myself do not understand or will ever know all of the unintended effects of tampering with a digestive process that took a few million years or so to evolve.  Are we so arrogant that we believe that these drugs only target gastric acid production? 

They are absorbed into the blood stream and course through every organ of the body.  Is it not conceivable that certain tissues might be sensitive to these foreign invaders?  Might there be unintended consequences that occur far downstream well beyond our horizon similar to a butterfly effect.    Do we really think that gastric acid is present just to bother us and it serves no useful function?


A minor change in a complex system can cause faraway effects. 

The human body is a supremely elegant, complex and integrated structure.  Tampering with one part of it may have wildly indirect consequences so far removed that we will not recognize the connection.  Consider these examples:
  • A certain class of antibiotics can cause rupture of the Achille’s tendon.
  • An anti-malarial medicine can cause nightmares.
  • Rotovirus vaccine can cause intestinal blockage.
There is science underlying the 3 examples above, but consider how implausible the causal connections between the drugs and the side-effects are?  Imagine what we don’t know.

This is why seasoned medical professionals prescribe new medicines sparingly.    A new vanguard of medicines has entered the arena.  Biologic medicines have stormed into the medical universe promising to stem the progression of many stubborn diseases such as Crohn’s disease, rheumatoid arthritis, psoriasis and ulcerative colitis.   We have all seen commercials for these agents on television, where the actors posing as patients are always fit and often engaged in some athletic activity.   These medicines, which tamper with the immune system by design, must be taken FOREVER.   The list of potential known side effects covers several pages in small print and range from life-threatening infections to cancer.  And, to repeat a line from this very post, imagine what we don’t know.  

The human body is a masterpiece of design and function.  When we pull on a thread, we may be distorting the far corners of the tapestry and never even realize that we were the culprit.

My advice to my colleagues and to my patients?  Be skeptical and humble always.

3 comments:

Md Anisuzzaman said...
This comment has been removed by a blog administrator.
Unknown said...

Hi Dr. Kirsch,
I just read your article on KevinMD and you are right on the mark, and would like to share my story. I've had GRD for over 25 years and my PCP in CA prescribed Nexium. After taking it for many years, it was removed from my insurance formulary and I switched to Previcid.

I've been a Health Plan Exec for over 30 years and currently post about 30 healthcare articles weekly on LinkedIn, Facebook, and Twitter. About 18 months ago, I saw article that referenced a JAMA article about Proton Inhibitors and it caught my attention.

It mentioned some conclusive evidence that drew a correlation between that drug family and CKD. By coincidence I've been CKD-3 for about 18 years, so I sent the article to my PCP in MI, asking if I should stop taking the Previcid.

I received a response from his medical assistant who passed along his response, "it's not a problem, stay on the Rx". It didn't feel right so when I had my 6 month follow up with my nephrologist about a month later, I brought the article with me. As soon as I mentioned it, he said it was one of the items he wanted to discuss, and told me to stop taking it, and moved me to a different family, an OTC med, ZanTac 150mg AM & PM.

I'm very close to my PCP, and at my next visit, I mentioned this to him and he was very embarrassed. While I fully believe my CKD-3 is related to my long-tern usage of Proton Inhibitors, it's not his fault, and there's no way he could have known.

The medications met FDA screening and were approved. If a long-term linear study was a perquisite for every RX, nothing would ever get to market. Currently, there's a class action lawsuit against Nexium, and while I'm not part of it, I believe they will be forced to pay a large settlement.

Your article resonated with me and I wanted to share my experience, and wish you a happy and healthy New Year.

Sincerely,
Michael Gould
President
ScripsNow
877-793-6733
810-885-2548 fax
805-320-5783 cell
mike@scripsnow.com

Michael Kirsch, M.D. said...

Michael, I'm sure readers appreciated your thoughtful and personal comments, as I did. To me the overriding theme from your remarks is the importance of being informed and advocating. I infer from your comments that you are aware that the medical profession must operate short of 100% certainty and that medical testing and treatment has inherent risks. Keep in mind that in your comment you correctly state that "...drew a correlation between that drug family and CKD...". The phrase 'correlation' or 'associated with' or 'linked to' does not mean causality, an important point often not grasped by journalists and ordinary folks. I hope that the blog will hear more from you in the future.

Add this