While doctors can prescribe drugs for any use, the promotion of drugs for these so-called “off-label uses” is prohibited by the Food and Drug Cosmetic Act.
Last May, federal prosecutors in Boston filed a brief in support of Franklin’s lawsuit, and have since been in settlement negotiations with New York-based Pfizer to recover money the Medicaid program spent on Neurontin.
Franklin’s lawsuit alleged that the company’s publicity plan included paying doctors to put their names on ghostwritten articles about Neurontin and to induce them to prescribe the drug for various uses by giving them tickets to sporting events, trips to golf resorts and speakers fees. One doctor received almost $308,000 to speak at conferences about the drug.
Neurontin’s sales soared from $97.5 million in 1995 to nearly $2.7 billion in 2003.” — New York Times
What is worth emphasizing is that it is not illegal for MDs to prescribe drugs for off-label uses; it is only illegal for the manufacturer to do any marketing for such purposes. What may have gotten Warner-Lambert (the Pfizer-owned company that pushed Neurontin, whose generic name is gabapentin) in trouble in this case, and netted whistleblowing scientist Franklin more than $26 million himself in the settlement of this lawsuit, is that this is the first anti-epileptic drug developed in the last several decades that does not turn out to have mood-stabilizing properties useful in psychiatric practice; clinical psychiatrists such as myself readily seize upon each newly-introduced anticonvulsant for our own purposes. (There are good scientific reasons to believe that a medicine with the one set of indications will also be effective for the other; in a nutshell, there may be similar physiological instabilities in brain function in at least some mood instability as there are in convulsive conditions.). I used an awful lot of gabapentin with my patients, on the basis of those reasonable assumptions, before my cliical experience and that of my colleagues began to tell me it might not be that useful. (Why did it take so long to figure it out? Because stability is a hard thing to verify except over time…)
I am amazed at Warner-Lambert’s ineptitude in its marketing practices, presumably blinded by the dollar signs in its eyes, in this case. Whenever a drug representative visits me (and I do not let it happen very often, and take no ‘perks’ from them when they do come), I am not interested in learning about the official indications for their products or the research data supporting the medication’s efficacy and tolerability, which is what they want to impart. I learn about medications from reading the peer-reviewed medical journals in my field,not marketing propaganda. I often try to persuade the reps to talk about the off-the-record, experimental, and projected uses of their medications, and 90% of the time they demur, citing FDA guidelines (although they will suggest references in the literature where I can explore these interests.) Maybe they think I’m an FDA ‘ringer’ or ‘narc’, but they usually cannot be trolled in the way Warner-Lambert was seemingly eager to be. By the way, this article is misleading in one sense. Companies do not give doctors speaking fees to induce them to prescribe the drugs; they only hire doctors who are already big users of the drugs (it has long since been the case that the pharnaceutical manufacturers keep a database allowing them to pull up data on every doctor’s prescribing statistics). Hiring a big booster of Neurontin, already in the bag, to do the speaking circuit is a way to get a credible authority to induce their colleagues to prescribe more Neurontin. Putting it more crudely, the doctors doing the speaking tours are the whores, not the johns.
(Footnote: it does turn out that gabapentin is probably useful for a variety of these off-label uses, including chronic headache and other pain conditions.).
