Plavix is the trade name given to the generic drug clopidogrel, as marketed by the firms of Bristol-Myers Squibb and Sanofi-Aventis, and was first approved for sale in the United States by the Food and Drug Administration (FDA) in 1997. The drugs functions as an anticoagulant; by preventing blood platelets from sticking to one another, it enables an increased blood flow, and was developed to reduce coronary problems: “It is a drug of choice for both acute and long-term treatment for individuals who have experienced a non-ST elevation myocardial infarction. Combination therapy with clopidogrel and aspirin reduces the risk of vascular events…” (King, Brucker, 2009, p. 457).
Since being approved for marketing, Plavix has become a widely identified and vastly popular prescription drug, chiefly administered to heart patients. It is marketed in over one hundred and ten countries, and U.S. sales have consistently been in the billions annually.
Plavix is not without issues, however, both in regard to adverse effects and its trade name life, as opposed to its generic future. Regarding the former, there has been widespread and unfavorable reaction to a single and consistently present side-effect: “Measuring its side effects, the Times stated that ‘Patients taking Plavix, a popular and expensive antistroke drug, experience more than twelve times as many ulcers as patients who take aspirin plus a heartburn pill” (Ellison, 2009, p. 63). Then, Plavix as such may not be enjoying its status as a leader in the prescription drug market for much longer: “The number one and two prescription drugs in the United States (Pfizer’s Lipitor…and Plavix with 2009 sales of $9.5 billion) are going off-patent in 2011, (and) the prospects for upheaval in the industry are high” (Warner, 2010, p. 129). While remaining an enormously popular drug, there are issues surrounding Plavix which demand serious focus.
No drug can be approved for distribution until strictly monitored clinical evaluations take place and provide acceptable results: “Although it is possible to predict, with varying accuracy, what a NCE (New Chemical Entity) will do when orally administered to humans, the full potential of a NCE is not known until it has been tested in clinical trials” (Smith, 2010, p. 2).
In the case of Plavix, two intensive trials were conducted, known as the CAPRIE and CURE studies. “CAPRIE was a 19, 185-patient, 304-center, international, randomized, double-blind, parallel-group trial comparing Plavix…with aspirin” (Ng, 2008, p. 201). The object was obvious: to contrast and compare occurrences of stroke, myocardial infarction, or any other vascular event as affected by the two substances. Plavix performed well, and clearly outdid the benefits of aspirin in these situations.
The CURE study was different in approach and aim, and utilized over 12,000 patients on a long-term basis. The test patients were randomized as well, and received treatment for up to a year, while simultaneously taking either aspirin or another usual heart treatment medication, such as heperin. A twenty percent risk reduction was determined from the Plavix usage (Ng, p. 202).
As has been noted, Plavix has enjoyed significant sales since its approval, and is typically ranked with Lipitor as a benchmark of pharmaceutical success. Bristol-Myers Squibb has, over the years, maintained its patent on clopidogrel, occasionally having to go to court to fend off intrusions and generic releases. In 2006, a Canadian manufacturer introduced a generic facsimile, but was ordered to cease production and distribution. Indian pharmaceutical concerns, well removed from Western jurisdictions, are free from such injunctions and market clopidogrel under the various names of Clopigrel, Clopitab, Clopijoy, and Clasprin. As noted, Bristol-Myers Squibb owns the exclusive Plavix patent until November of 2011.