Cleveland Clinic's Dr. Nissen To Lead 20,000 Patient "Precision" Clinical Trial
In mid-December 2005 the drug company Pfizer Inc. announced that Dr. Steven E. Nissen, medical director of the Cleveland Clinic's cardiovascular coordinating center, will lead a large-scale clinical trial to compare three of the most commonly used painkillers -- Pfizer's Celebrex, and prescription-strength doses of ibuprofen and naproxen -- among arthritis patients who also have pre-existing cardiovascular disease or who are otherwise at high risk of heart problems.
In laymen's terms, the "end point" of this massive study will be to answer this simple question: What is the safest medicine for these patients to control their pain?
Earlier in 2005, the FDA mandated that increased warnings be added to the package insert labels of Celebrex, a COX-2 inhibitor, as well as ibuprofen and naproxen, which are non-steroidal anti-inflammatory drugs (NSAIDs). The reason behind this FDA action was that some clinical studies had raised concerns that Celebrex and the two NSAIDs, like the recalled painkiller Vioxx, may increase a patient's risk of having a heart attack, stroke, or other serious cardiovascular event. The problem for the FDA, not to mention doctors and their patients, was that these previous studies were not definitive on the cardiovascular safety issue. In part, that "uncertainty" problem was the result of the fact that there had not yet been any large-scale clinical studies of Celebrex, or the two NSAIDs, which focused on patients who had one or more pre-existing risk factors for cardiovascular disease.
The aim of this new Pfizer-sponsored clinical study -- which will be called "Precision", according to Forbes reporter Matthew Herper -- is to track incidents of cardiovascular deaths as well as non-fatal heart attacks and strokes in order to determine whether Celebrex, ibuprofen, and/or naproxen are safe for use by patients already at risk for serious cardiovasucular side effects.
To this end, the Pfizer study will enroll 20,000 patients "worldwide" (actually just Australia, the U.S., Eastern Europe, and Switzerland, according to a December 13, 2005 Forbes online article by Matthew Herper) over an eighteen-month period. Those patients will be followed for an average of two years, at a cost to Pfizer in the range of $100 million. The results of this "Precision" study are expected to be available in no less than four years.
In a December 13, 2005 article in The Wall Street Journal, Dr. Nissen commented:
- "The public and the medical community are confused.... The relative safety of these three drugs is simply not known. We're going to answer the question are they the same or are they not."
- "There has been an erosion of public confidence in this class of drugs.... We need to get an answer that is done in a way that is completely transparent."
Not all medical researchers, however, believe this Pfizer-sponsored study is a good thing. For example, Garret FitzGerald, a renowned pharmacologist at the University of Pennsylvania, thinks giving Celebrex or the two NSAIDs to patients already at a high risk of having a heart attack or a stroke may be "ethically questionable", according to the December 13 Forbes article. That article by Mr. Herper states, also, that Dr. FitzGerald "expressed concerns that the study could be just a way to buy Pfizer some more time."
According to news reports, the first patient will not be enrolled in the "Precision" clinical trial until some time in 2006.
(Posted by: Tom Lamb)