Of all media sources you don’t usually expect in depth, balanced features from USA Today. But Tuesday’s USA Today has an excellent article by Julie Schmit on how Warner-Lambert (and now Pfizer’s) Neurontin went from being a minor epilepsy drug to a major CNS blockbuster. In 2004, the last year before it goes off patent, Neurontin will do over $3bn. Not Lipitor, but a pretty respectable number.
The answer is that Warner-Lambert promoted the off-label use of Neurontin from 1994, when it was introduced, to 2002, when it was given an additional approval for pain from shingles. The story:
Warner-Lambert’s offense was marketing Neurontin to doctors for purposes other than as a supplemental anti-seizure medication for epileptics. That was the only use approved by the Food and Drug Administration during Neurontin’s early years, when prosecutors say Warner-Lambert’s illegal marketing took place.
The Justice Department says that’s what Warner-Lambert did from shortly after introducing Neurontin in 1994 until 2000. Prosecutors alleged that Warner-Lambert lied to doctors about the drug’s effectiveness, paid doctors to allow a sales representative to sit in on sessions with patients and paid doctors, some up to $250,000, to unethically talk up Neurontin to other doctors. In fact, the list of ailments that Warner-Lambert claimed Neurontin alleviated was so long — covering pain, headaches, bipolar disorder, attention-deficit disorder, alcohol detoxification — that some Warner-Lambert employees dubbed it the “snake oil” list, government documents say.
The strategy worked. In 2002, 94% of Neurontin’s sales were for off-label uses, up from 40% in 1995, the government estimates, citing company documents and independent market research. Wall Street firm Lehman Bros. estimates that 90% of Neurontin sales are currently off-label
So Pfizer, having got Neurontin as a side dish to what it really wanted (Lipitor) when it bought Warner-Lambert, inherited the good and the bad with it. By 2002 the horse had left the barn and Neurontin was being prescribed for virtually anything that doctors and patients felt it might work for. Now that’s not necessarily a bad thing, and its very common. As PhRMA likes to point out, the FDA tends to be over cautious, but the same drug works differently for different people, and if a drug is doing some people some good who’s to blame them for using it and doctors for prescribing it. As one quoted patient says: “If it doesn’t work, then why do I feel better?”.
But that’s exactly the same argument made for medical marijuana. And while DOJ is massively over-zealous in enforcing its perception of the law in that case (at great cost to patients and society), fining Pfizer $430m for violating marketing practices over 8 years (although the admission is only up to 1996 not 2002) on a drug which is probably dropping more than $2 billion to the bottom line this year is not exactly vigorous retribution. But that is the typical state of play. It’s how the pharma business has worked for a long time and it’s unlikely to change any time soon, even if the DOJ chief’s name in February 2005 is Spitzer.