I stumbled across this news article on a law suit about Neurontin the other day and thought it was interesting:
Top drug company marketing executives suppressed a large European study suggesting their blockbuster medication Neurontin was ineffective for chronic nerve pain, and they privately strategized about how to silence a British researcher who wanted to go public with the data, according to newly filed documents and e-mails that are part of a Boston court case.
During the same period of several years, Pfizer Inc. launched an advertising blitz promoting the purportedly positive findings of a smaller Neurontin study it had published in a major medical journal – including showing a video to airline passengers before their in-flight movie.
The widespread promotion of Neurontin turned what had been a relatively minor epilepsy drug into one of the fastest-growing blockbuster drugs in the world, one that generated more than $2 billion a year in US sales for Pfizer before a generic competitor entered the market in 2004.
Taken together, the e-mails and other internal Pfizer documents produced as part of a potential class action lawsuit against the company represent one of the most detailed looks yet at how a drugmaker controls what physicians and consumers know about a drug.
Here’s what struck me about the article: 90% of gabapentin’s (Neurontin’s) sales are for what are called off-label use, i.e. for uses other than those for which efficacy has been demonstrated to the FDA. How do physicians know about these off-label uses?
One possibility is by observation. A physician may have observed that some of their patients being treated with a drug for the condition for which the drug has been approved show improvements in other areas. Another possibility is word of mouth, either on the part of other physicians or patients. However, it seems to me the most likely explanation is advertising in the form of studies produced by the pharmaceutical company that produces the drug. It’s possible the studies are distorted, misleading, or selective. As the article cited above suggests, how would they know?
The motivations of the pharmaceutical companies in this regard are obvious: $2 billion is a lot of jack. And a cadre of physicians or patients who believe they’re being helped by something can provide a powerful advocacy arm.
I’m even beginning to wonder about the claims of efficacy that have been accepted by the FDA. Take the example of the only two drugs (to my knowledge) that have beeen approved for use in the treatment of fibromyalgia: pregabalin (Elavil) and duloxetine (Cymbalta). Have any longitudinal studies been done that demonstrated the effectiveness of these drugs over time? I’ve written before about the commonplace experience of patients becoming inured to a drug. A typical reaction by physicians to that is to up the dosage despite the frequent fact that higher dosages of some drugs have never been demonstrated to be effective. Scientific medicine, indeed.
But back to off-label. Can somebody explain to me why off-label use, use in which a drug may not have demonstrated efficacy, is ethical, why it’s not malpractice? I recognize that in oncology, for example, the overwhelming preponderance of drugs are being used off-label. Is that an excuse? Is something always better than nothing? I don’t believe so. Prescribing ineffective drugs moves resources from other, possibly more productive uses.
IMO we need a major revision in the entire system by which drugs come to market. The incentives today are so high, the methods so antiquated, the conflicts of interests so manifest, the resources of the government agencies so limited, and the consequences possibly so severe that change is really overdue.