This headline caught my eye on Dr. Mercola’s site. He writes an article about some of his medical predictions that came true, despite being out of step with conventional medicine at the time. His prediction about the discontinued drug Vioxx really hit home, as I made a similar “prediction” in 2001. The link is to Dr. Mercola’s article, and my story is below.
In the winter of 2001/2002, I was a nurse abstractor for a study on Congestive Heart Failure. My job was to review medical records (charts) of managed care patients who had been hospitalized that year for Congestive Heart Failure (CHF). The study was being managed by an External Quality Review Organization (EQRO) and our objective in the chart reviews was to discover if the patients had received testing for Ejection Fractions and if so, had they been started on an ACE inhibitor protocol if appropriate, as well as determining if other medication protocols had been adhered to.
It was an interesting study, and it required a meticulous review of one year’s worth of medical records for each selected patient, both inpatient and outpatient. I have always found these comprehensive chart reviews to be one of the most educational things I have done in nursing. If you have never had the opportunity to read every word in a year’s worth of medical records, I would encourage you to do so. You will most likely find a glaring lack of continuity in our healthcare system with very little coordination between hospital admissions, outpatient visits, specialist visits, ER visits, and Rehab admissions. It’s interesting to track the medication changes with each entity, and notice the complete lack of continuity in that area. No great surprise that most patients are confused about the meds they are taking and usually are taking them incorrectly! But I digress into another topic for another day.
While reviewing these CHF charts, I began to notice a rather disturbing trend. A large percentage of the patients with ER admissions for new onset CHF had recently started on the new NSAID from Merck, Vioxx. This observation was purely incidental and had absolutely nothing to do with the study. It just seemed, to my mind, that the connection between Vioxx and CHF was happening too frequently to be coincidental. I mentioned this to some of my fellow nurse reviewers over lunch, and they concurred. We started asking other nurses on the project if they noticed this trend, and it didn’t take long before we were all growing quite suspicious of Vioxx.
To make a long story short, a group of nurses reviewing medical records making an inference that there is an association between one of the most prescribed new drugs on the market and adverse cardiac events doesn’t wield a great deal of power and influence in the medical establishment. When we voiced our concerns to the study manager, she was sympathetic, but reminded us that we were veering away from the purpose of our study.
In the end, the best I could do was to encourage friends to stop taking Vioxx. It was almost 3 years later, in September of 2004, when Vioxx was pulled off the market. FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market.
In healthcare, we have lots of buzz about Evidence-Based Medicine and Outcome Measures. In the past decade, even more nurses have taken on Quality Management roles and the utilization of nurses in retrospective chart reviews is increasing. In a perfect healthcare system, we would have nurses reviewing a year’s worth of random patient records and looking for trends. Nurses are naturals at noticing the details. I am convinced that if we formed a task force of nurses in each healthcare setting to review patient records and make recommendations based upon what they NOTICE, we would have a greatly improved and more efficient healthcare system. Probably one of the most frustrating things about nursing is knowing what is wrong and being powerless to do anything about it. I’m still not sure how we, as a profession, can remedy that. I remain hopeful that our new nurses will find an answer.