With A Capital T

I volunteered to give a Grand Rounds talk to the Stamford Hospital Medical Staff on a topic that is hot in Gastroenterology and has been bugging every GI doc in the US for the past year. The topic is the use of anti-acid Proton Pump Inhibitor medications (Prilosec, Nexium, Protonix, etc.) along with Plavix, a blood thinner that is used, among other things, to prevent clotting of coronary artery stents. Last year a French study said that PPIs could interfere with the anti-platelet effect of Plavix and possibly cause coronary stents to clot off leading to heart attacks and death. That single study, which was done in test tubes, not lab animals or people, was publicized by the news media, embraced by cardiologists and pharmacists, and has caused many doctors to have their patients stop taking PPIs. It has also caused many patients to stop taking PPIs on their own or at least question their Internist, Cardiologist and/or Gastroenterologist. Last November the FDA got into the act and now recommends against the use of both Prilosec and Nexium with Plavix.

I am in the process of deciding how to approach my talk and hope to use you, my readers and friends, as a sounding board to help me focus and organize my thoughts. Let me jump to the bottom line first. Although some PPIs do interfere with the activation of Plavix in the test tube, in real life prospective studies published in the past year, done on people, there has been no increase in heart attacks or death in those co-treated with PPIs and Plavix. The only increase in morbidity (bad stuff happening short of death) or mortality has been secondary to GI bleeding from stopping the PPI. PPIs have been proven to heal ulcers and protect against GI bleeding. If someone has an ulcer or some other GI lesion that could bleed, drugs like Plavix make the bleeding much more severe and difficult to stop. America’s foremost Cardiologist, Eugene Braunwald, the Harvard guy who writes the foremost Cardiology textbook, wrote a paper saying that we should not stop PPIs in our patients who are taking Plavix but rather get back to thinking about preventing GI bleeding. Still, I get calls daily about my patients being taken off PPIs because they have been told the whole class of drugs will cause them to have a stroke, heart attack or die.

Am I the only doctor reading the literature? No, I’m not. I’m going to try not to let my anger or frustration get in the way during my talk. The studies are out there and I’ll present them. That, however, is not enough for me. I’d like to open a discussion on how we doctors do or should respond to new medical studies, all of which these days appear in newspapers, TV news, talk shows and the like. Do we give in to mass hysteria? Do we wait for corroboration or expert opinion? Do we act based on how it affects our income?

Last spring I gave another Grand Rounds, along with a panel that included a cardiologist and hematologist, on the use of blood thinners in patients having GI endoscopic procedures. The PPI/Plavix issue had just started and I was asked for my opinion. What I said was that more study of the topic was needed, as in fact was recommended by the original study’s authors. In the interim, because of the serious question of stents clotting off, heart attacks and death, I said that it would be prudent to use another anti-acid medication if possible and to make sure if a PPI was to be used along with Plavix, that it was being used for a strong indication. Now, a year later I’d like to practice evidence based medicine and tell my patients not to stop their PPI even if they get a new stent and are put on Plavix. Unfortunately, with Cardiologists and Pharmacists, not to mention the FDA, still saying to stop the PPI, I can’t, without creating discord and setting myself up for potential litigation if a bad outcome would occur. I’m facing a tail wags the dog situation where the established untruth trumps evidence and expert opinion. That’s what I’d really like to talk about.

There are billions of healthcare dollars being spent on unproven procedures and treatments. Even when expert guidelines and recommendations exist (remember my mammography blog?), public opinion and inertia and fear and greed rule. I wonder how popular a theme that would be for grand rounds? Better, I guess, to be a team player, give the public what they want and let me and my colleagues keep selling you stuff you don’t understand and can't use—to use a Music Man analogy, expensive musical instruments that you teach yourselves to play by concentrating, Professor Harold Hill’s think system. Friends, we got trouble right here in River City. That’s Trouble with a capital T that rhymes with P and that stands for PPIs and Plavix.

Harold Hill: A man can't turn tail and run just because a little personal risk is involved. What did Shakespeare say? "Cowards die a thousand deaths, the brave man... only 500"?

http://www.youtube.com/watch?v=s60hOgqLFGg