Eight years ago, the FDA approved the powerful narcotic only for use by cancer patients who are already taking a long-acting, chronic painkiller but suffer from severe spikes in pain. But a recent study conducted by Prime Therapeutics (Prime) found 90 Percent of Actiq Lollipop prescriptions are off-label, which could account for the upward spike in their profits -- Cephalon acquired Actiq in 2000, and reported sales of $15 million. By 2006, sales in the first nine months reached $471 million, ranking it second place in Cephalon's arsenal.
Once a drug has been approved by the FDA for prescription use, it is up to the physician to regulate and decide who receives the drug, based on his best judgement. In the US, it is legal to use drugs off-label with the exception of controlled substances such as opiates, which cannot be legally prescribed except for approved purposes. Actiq lollilop is a man-made opiate, a powerful synthetic opioid also known as fentanyl.
The results of the Prime study confirmed concerns about the drug. Even before Actiq was approved in late 1998, the FDA had concerns about Cephalon and its risk-management program - which states that salespeople can only promote the product to target audiences, i.e. in the case of Actiq, oncologists, pain specialists, their nurses and office staff. Fast forward five years: in 2003, a Cephalon auditor reported that the company did not comply with the FDA program. (He was subsequently fired and filed a lawsuit against Cephalon for wrongful termination. According to the lawsuit, Cephalon offered the auditor, Mr. Brennan, money and job-search assistance if he agreed not to disclose the audit, but he refused.)
The FDA program then required that Cephalon report to the FDA every quarter to determine whether or not groups of physicians who represent potential off-label usage greater than 15 percent are prescribing Actiq. If this is the case, Cephalon must warn doctors against off-label use - meaning all non-cancer prescriptions.
But Cephalon doesn't agree with the 15 percent clause. The drug maker says it only needs to warn doctors " if any individual specialty exceeds 15 percent of the total -- and then only if it can be shown that doctors in that specialty are prescribing Actiq inappropriately."
Meanwhile, reports are coming in where pregnant women have been prescribed Actiq lollipop for migraines. The drug is so addictive that one woman spent her entire pregnancy on one big high, sucking lollipops until she gave birth. Needless to say, her baby was also born with an addiction to this powerful narcotic.
Off-label prescribing isn't illegal, but it can be dangerous, particularly when a drug such as Actiq has a high potential for abuse. Some people have died from an Actiq overdose. Isn't it about time that Cephalon curb its aggressive marketing techniques?
Cephalon says it doesn't market the drug for unapproved uses, yet its sales representatives contact a wide range of doctors, not just oncologists. Sports medicine doctors and family physicians have been left with free samples, fortunately for many patients who cannot afford the price tag. (A pack of 30 sticks costs $502, each containing 200 micrograms of fentanyl.)
Cephalon acknowledged that Actiq is widely used off-label, but it says it can't control how doctors prescribe the drug. Unfortunately for many patients who have taken Actiq, they cannot control it either.