Questions About the Use of Plavix With or Without Aspirin
Anticoagulants, inaccurately called "blood thinners," are clotting inhibitors which are both used and overused in medicine. The combined use of these drugs, particularly aspirin with Plavix© has received a great deal of attention recently, and caused, in some quarters, increasing apprehension. The supine acceptance by the medical profession of the antiplatelet drug Plavix is another frightening example of the payoff from a pharmaceutical media blitz. Thanks to manipulative marketing, sales of the drug, made by Sanofi-Aventis, distributed here by Bristol-Myers Squibb, are up 60% in the past two years to over $6 billion worldwide, making Plavix second only to Lipitor© as the best selling drug in the world!
But is it possible that Plavix© is safe, and at the same time a therapeutic triumph that saves lives? The drug, like aspirin, interferes with blood coagulation via its inhibiting effects on the same target, platelet function, but by a different mechanism, and is routinely used to prevent clots developing before and after the placement of cardiac stents. However, its safety and superiority over aspirin and heparin in pre-treatment before stent placement has been widely questioned, and is in fact, except in emergencies, an off-label use. ("Off-label use," though strictly speaking, legal, means the practice of prescribing drugs for a purpose outside the scope of the drug's approved label.) An increasing number of physicians do not realize they are prescribing Plavix off-label when it may not indicated. Note the following:
"Clopidogrel (Plavix)...is not approved for PCI or stent placement outside of the setting of ACS [Acute Coronary Syndrome]." In other words, the use of Clopidogrel in patients who receive stents in non-emergency situations is an off-label and unapproved use, according to the Center for Drug Evaluation and Research (CDER), the FDA division that regulates the pharmaceutical industry." See this site.
Plavix alone or combined with aspirin, is also being used for millions of patients, who are assumed to be at increased risk for heart attacks and strokes. However, a study of 15,000 patients published last year found that adding Plavix ($1.50-$3.00 a day) to low dose aspirin (2-3 pennies a day) was no more effective than aspirin alone for preventing heart attacks, strokes, and cardiovascular deaths. In fact, Plavix plus aspirin, a risky combination, nearly doubled the heart disease death rate, and caused many patients severe bleeding problems, especially in elderly patients with minor head trauma.
The New England Journal of Medicine (NEJM) published a study three years ago showing that patients taking Plavix, experience more than 12 times as many ulcers as patients who take aspirin plus a heartburn pill. Up to half of those now taking Plavix do so because their doctors have been told and assume that Plavix is safer on the stomach than aspirin, said the study's lead author. Another article in the NEJM (Oct. 3, 2007) pointed out the dangers of dual anticoagulant therapy (Plavix or Coumadin with aspirin) "...Increased risks not always offset by benefit…", meaning serious or life-threatening bleeding.
A storm of class action lawsuits against the manufacturers of Plavix have been initiated over the past few years. According to this site their lawsuits allege:
- "Plavix is defective in its design and formulation"
- "Safer alternatives to Plavix are available"
- "Plavix is unreasonably fit, suitable or safe for the promoted uses"
- "Potential for Plavix side effects outweigh the benefits associated with the drug"
The manufacturers of Plavix, Sanofi-Aventis and Bristol-Myer Squibb, have received several FDA warning letters regarding false and misleading statements made in promotional materials for Plavix. These FDA letters clearly indicate that the manufacturers were more concerned with increasing sales, even at the expense of providing fair and accurate information to consumers and physicians. "At the time Plavix was developed, the makers own studies demonstrated that the drug was not any better than aspirin at preventing heart attacks and strokes. Through proper evaluation of clinical trials, the limited benefits and increased risk of heart attacks, strokes, internal bleeding and death should have been apparent."
But wait: Drug makers may be achieving a long-awaited legal shield. Thanks to the effort of the Bush Administration and a novel legal argument called pre-emption. This doctrine which holds that the FDA is the only agency with expertise to regulate drug makers and that its decisions should not be questioned or second-guessed by the courts. If this doctrine is supported as the new legal standard, it means, even if the FDA is mistaken in a given approval, -an increasingly common event given the current problems of scientific competence at the Agency, the original approval cannot be questioned. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. The FDA is now arguing in court that Johnson and Johnson cannot be sued by thousands of women who suffered serious and fatal blood clots and strokes from OrthoEvra birth control patches even though the old label approved by the FDA itself inaccurately described the amount of estrogen it released.
The anticoagulant conspiracy represents a new multibillion pharmaceutical dollar growth industry backed by investors inspired by authorization of coverage by Medicare and private insurers. For further revelations and detailed documentation of these and numerous other conflicts of interest and widespread corruption in industry, medical centers, and the medical profession check out this site, Dr. Paul Rosch's, The American Institute of Stress Newsletter, especially, the June 2006 issue.
A word of advice: If your doctor has you on aspirin plus Plavix, or Plavix alone for heart or stroke prevention, ask him to tell you the advantages, benefits, costs, and the risks of Plavix or Plavix with aspirin vs. aspirin alone.
Martin F. Sturman, MD, FACP
Copyright 2008, Mathemedics, Inc.
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