Limit Physicians’ Off Label Prescribing Practices?
Off label prescribing has become fairly common practice for many medical professionals. Once a drug has been approved by the Food and Drug Administration (FDA) for a specific purpose, physicians are given the freedom to prescribe the approved drug “off label” for other beneficial uses of the drug. There is a great interest for physicians to retain this autonomy of prescribing drugs off label as the practice expands treatment options. Both the American Medical Association and the FDA have recognized that physicians are in the best position to determine the method of treatment for their patients.
However, the practice of off label prescribing has not been without controversy. Many politicians and regulators view off label prescribing as a way to avoid clinical testing and FDA approval process. In addition, studies have shown that many physicians prescribe off label with little or no scientific rationale. According to the Daily News Central, an example can be found in a particular study: “in all, the study estimated that 1 in 7 prescriptions were written [by doctors] without good medical evidence that they would work.”
A LA Times article has recently highlighted the problems of off label prescriptions. In the article, it has come to light that the off label use of statins, one of the world’s most prescribed medication, may not have the efficacy that many doctors had previously thought. The LA Times reports,
Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose — called “secondary prevention” — the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.
Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins — called “primary prevention” — has driven the growth in the market for statins over the last decade.
Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease but it’s not so clear they work that way in people who are healthy. In spite of that uncertainty, statins’ use for primary prevention has sky rocketed.
One wonders how so many physicians came to believe that statins could also reduce the risk first time heart attacks. Dr. John Abramson, from Harvard Medical School, attributes statins’ off label growth to a “conspiracy of false hope.” He states, “[t]he public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”
So, with all these interests pushing for statins’ off label use, it should not be a great surprise that extensive research has not been performed regarding statins’ primary preventive effects– and conflicting results have emerged. The LA Times reports,
In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”
Potentially, new findings regarding the efficacy (or lack thereof) of statins can have seismic effects. If it is found that statins’ primary preventative effects are overstated or nonexistent, this would amount to what has been a tremendous amount of healthcare waste (time, money, and effort) due to the popularity of the drug. According to IMS Health, U.S. patients filled 201.4 million prescriptions for statins last year alone.
While there is a strong interest for physicians to retain their autonomy when assessing the best treatment for the patient, due to the potential of healthcare waste, there may be an equal or if not stronger interest for some regulation regarding the practice of prescribing off label drugs. As to industry funding of research, there seems little incentive for a pharmaceutical company with a blockbuster off label hit to do anything which would upset the apple cart– or should I say money cart?
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Will healthcare reform limit a physician’s ability to prescribe drugs for off label use?