March of the Clones

For those of you who don’t know, when a drug is approved by the Federal Food and Drug Administration (FDA) it receives an indication which specifies its use. In order to maximize the profitability of their drugs, pharmaceutical companies initiate new clinical trials or sponsor research to search for additional indications and, if the data are favorable, they will file with the FDA for a new indication.

What is at issue here is not the new clinical trials or the new indications, but promotion of a new indication of a drug without proper approval by the FDA (off label promotion). This is a common tactic used by pharmaceutical companies. Companies employ teams of very attractive females and males (clones) to encourage physicians to write more scripts for the drug they are selling. Doctors that are targeted according to their practice area and could be visited by these clones several times a day. The clones are armed with a multitude of selling devices, such as money for lunch and, if available, copies of studies showing new uses for their drug. The clone then mentions the suggested new use with the hopes that the doctor will prescribe more of the drug. This is highly improper and endangers public health. Just to be fair, however, not all pharmaceutical companies engage in this activity.

The costs are high when companies get caught engaging in this activity. For example, Neurontin was originally indicated for diabetic neuropathy. Teams of medical liaisons, i.e. clones with advanced degrees, traveled to doctor’s offices to show them studies opening up new uses for Neurontin (sometimes these liaisons promoted new uses without studies). Their tactic worked as doctors began to prescribe Neurontin for all sorts of off label uses, including depression, bipolar disorder, and epilepsy. The joy was short lived, however, as Neurontin’s manufacturer Warner-Lambert was hit with extensive criminal and civil charges and eventually agreed to pay $250 million criminal fine, $83.6 million to the Federal government, and $38 million to consumers [see Drug Maker to Pay $430 Million in Fines, Civil Damages]. This example shows you that the risks are high but so is the return. A company can open itself up to 100s of new customers by promoting off label use.

So here we go again, Cephalon is the manufacturer of two extremely potent pain medications that are both indicated for acute cancer pain, the Fentora lozenge and Actiq lollipop. Cephalon is currently under congressional investigation of its marketing practices of its Fentora and Actiq product [see House Lawmaker Seeks Data From Makers of Stents and Drugs]. There have been reported four deaths recently attributed to the Fentora lozenge [see Cephalon's Fentora linked to four deaths; labeling revisions under discussion, spokesperson says] and Actiq has been noted to be prescribed for off label uses.

When is this going to stop? Never. As long as there is huge profit margin and an overworked and understaffed governmental agency, pharmaceutical companies will take advantage of the situation and the clones will continue to march to the cries of the consumer.