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Explain the difference between "off-label" and " improper marketing" of drugs. Comment on how Neurontin fits into it.

Dr. Eric

I'm afraid we're mixing up two different problems here. One problem is "off-label" uses of drugs. The other problem is improper marketing of the drug.Firstly, "off-label" uses of drugs are neither illegal nor quackery. Many drugs, perhaps most drugs, are used for off-label purposes. In the case of Neurontin, the FDA approval was given for epilepsy, because those were the data that the company submitted to the FDA in their New Drug Application.

After the drug was approved for use in epilepsy, some doctors noticed that it also helped relieve neuropathy. A licensed physician in the US can prescribe any FDA approved drug for any purpose. The doctor will get in trouble if the drug has no rational use for that condition, but only in clear cases of malpractice will there be any action against the doctor. For instance, if a doc prescribes penicillin to treat cancer, there is no rational association, and he/she is beyond the defensible scope of clinical practice. However, using a neurological agent like Neurontin for peripheral neuropathy is logical, supported by anecdotal evidence, and can be demonstrated to be effective. Even though this is an "off-label" use of the drug, there is no problem for the doctor to do this. The problem arises when an off-label use is shown to be ineffective or (worse) contraindicated, and the doc continues to use the drug. In those cases, the doc can be held liable for improper use of the drug. That was NOT the case with Neurontin and peripheral neuropathy.

The second problem, and the one that is at issue in the Pfizer case, is the company's "improper marketing" of the drug. The improper marketing has nothing to do with off-label uses. A drug company can promote a drug for off-label use if they have independent papers to support the off-label use. The problem in the Pfizer case is that the company was PAYING doctors to prescribe the drug for off-label uses. This is a kickback and is strictly forbidden. Pfizer got caught and paid a large (multi-million dollar) fine for this practice. Pfizer would have been fined even if they had been paying the doctors to prescribe Neurontin for patients with epilepsy. The problem is paying the doctors, not the off-label uses.

The attorneys have jumped on this case, and are trying to get a bunch of people together to form a class action lawsuit. Their hope is that Pfizer will look at the cost of litigating such a suit, and will settle out of court. In a class action lawsuit, the lawyers make a ton of money, and the individuals in the suit make a few ounces. For example, I was part of a class action lawsuit against a large credit card company. The company paid a fine of close to $100 million. The lawyers collected $95 million of that, and the rest was divided among the members of the class. I got a check for $1.00.

What Pfizer did was wrong, but it has nothing to do with promoting Neurontin for periperal neuropathy. Neurontin is a very effective agent for most patients with peripheral neuropathy, and the use of the drug for that diagnosis will never be challenged from a medical point of view.

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