Many would consider the relation between the pharmaceutical industry and doctors cozy, perhaps even conspiratorial. With governments in many countries, tightening the noose on the industry regarding what it could give as gifts or incentives to doctors, and doctors increasingly having to declare their interests in pharmaceutical companies on whose products they are researching or commenting, among other recent developments regarding the relationship between both, questions have certainly come up. No doubt, both doctors and the pharmaceutical industry merit commendation for their efforts to relieve patients of the agony of illness, not to mention the ripple effect of these efforts on the economy, among others, the savings derivable from reduced morbidity and mortality, and from buoyant health indicators.
Yet, the interactions between the triad of doctors, the pharmaceutical industry, and patients remain under scrutiny and would likely be even more so, in the years ahead as new issues emerge that would trigger new questions about these interactions. Erythropoietin, for example, is an intricate recombinant glycoprotein hormone approved for treating anemia in dialysis patients, those, on cancer treatment, and after major surgery. A systematic review of its off-label use in critically ill patients, in the September 25, 2007 issue of the Canadian Medical Association Journal (CMAJ) 1, addressed one such key emergent issue.
Johnson & Johnson and its subsidiary Janssen-Ortho have invested substantially in major clinical trials, for an indication for the use of this drug in gravely ill patients. However, its seemingly aggressive promotion without an approved indication among critically ill patients1, by its makers via direct-to-consumer (DTC) advertising and inducement payments to doctors, is causing consternation in some quarters, regarding not just its off-label use, but off-label indications in general. Indeed, concerns regarding aggressive marketing practices of off-label medication use resulting in the practice becoming pervasive, with potential patient safety implications have provoked an inquiry by the U.S. Congress2.
In some instances, off-label drug use has resulted in litigation, the use of the anti-seizure drug, Gabapentin, in chronic pain management for example, resulting in criminal liability and civil damages against its manufacturer, Warner–Lambert3. Other instances of off-label indications have reportedly even increased the risk of death in patients4, 5. No doubt, the issue of off-label indications is becoming increasingly sticky as arguments for and against it abound. The systematic review mentioned earlier noted for instance, that erythropoietin treatment costs about $400 per dose, but saves averagely in these patients, not up to a unit of blood, with no improvement in clinical outcomes and potential thrombotic problems.
Nonetheless, off-label indications, often an offshoot of clinical experience of on-label (approved) use, could stimulate research and foster medical progress, in keeping with which some support discretionary off-label medication use, although others query how autonomous such discretions really could be with pharmaceutical firms aggressively promoting off-label indications. In effect, they argue that these firms are able to circumvent regulatory oversight and make added profits, and with for example a fifth of prescriptions for frequently used drugs were off-label, about a third of which lacked validity5, patient safety becomes a significant issue. In fact, U.S. Institute of Medicine recently issued a report that was a pungent critique of the drug safety system of the Food and Drug Administration (FDA) 6.
Titled, “the future of drug safety: promoting and protecting the health of the public,” the report included twenty-five recommendations centered on clarifying FDA’s power, on enforcing its authority, and on stricter drug safety laws including tighter labeling requirements and advertising limits for newly approved medications. With the occurrence of about 1.5 million, perhaps even more, preventable adverse drug events (ADEs) in the
It could only be conjectural for example, the difficulties that organizations such as the FDA in many countries would have addressing the problems of off-label indications given these being the first set of tangible steps advocating federal action in the US against preventable drug catastrophes after the rofecoxib (Vioxx) quagmire. With the backdrop of the report being public perception of the drug safety system being in crisis6, and the September 2004 sudden withdrawal from the market of the blockbuster arthritis medication, Vioxx due to the "increased risk of serious cardiovascular events, including heart attacks and strokes"8 not to mention costs issues, drug regulatory agencies worldwide need a facelift.
Regarding costs for example, to patients, their families, their employers, and to hospitals, health-care providers, and insurance companies, a study found that each preventable ADE that occurred in a hospital meant about $8,750 (in 2006 dollars) to the cost of the hospital stay. If 400,000 ADEs occurred annually, a conservative estimate, the total annual cost would be $3.5 billion in this group alone, according to the IOM7, not to mention lost earnings, or any compensation for pain and suffering, among others.
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