Narcotic manufacturer Cephalon is back in the news, once again facing an investigation focused on the use of Fentora, a Schedule II narcotic, in workers comp cases.
Fentora is only FDA approved for breakthrough cancer pain – a condition quite rare in workers comp. The investigation apparently stems from allegations around Cephalon’s efforts to promote the use of Actiq(r) and Fentora(r), their highly potent narcotics for workers comp patients.
Those efforts were quite successful, estimates indicate ” in the first half of 2006 approximately 99% of the 187,076 Actiq prescriptions filled in the U.S. were not for cancer patients.”
Cephalon recently disclosed the following: “In January 2011, we received a subpoena … in connection with an investigation relating to Postal Service employees’ workers’ compensation claims. The subpoena requests that we provide to the Postal Service documents pertaining to FENTORA. We understand that this investigation is being conducted by the Postal Service in conjunction with the Civil Division of the United States Attorney’s Office in Philadelphia.” (from Cephalon’s latest SEC filing).
This latest investigation is not exactly the first instance of this type of conduct. In fact, in an earlier court ruling, the judge said “data suggested that more than 80% of patients using Actiq did not have cancer,” and “oncologists accounted for only 1% of Actiq prescriptions filled at retail pharmacies in the U.S.” [emphasis added] It is possible that oncologists are dispensing Actiq from their offices, although that’s rather difficult and complicated due to rules and regulations about storage and protection of Schedule II narcotics.
In 2007 Cephalon paid $425 million in fines and interest stemming from its promotion of off-label use of another narcotic opioid – our old nemesis Actiq, and another $6+ million to the state of Connecticut for similar reasons. They are also facing RICO (racketeering) and other charges related to allegations Cephalon’s promotion of Actiq and other drugs violated several laws.
As recently as 2008, Actiq was one of the top five drugs in workers comp measured by dollars spent for many payers; Fentora appears on most PBM’s lists of the top 25 drugs.
But it’s not just about the dollars. Actiq has been linked to dozens of deaths from overdose, including one case in Kansas where a doctor operating what can only be described as a ‘pill mill’ was indicted for involvement in fifty-six patients.
Roy Poses wrote four years ago that Cephalon had admitted Actiq was involved in the deaths of 127 people.
It is indeed possible more have died since then…
Thanks to Mike Whitely writing in this am’s WorkCompCentral for the tip.
Feb
16
Who is really to blame here Joe? I have a pharmacy specializing in Workers Comp prescriptions, and in 10 years I have never filled a single Actiq prescription. Have we gotten prescriptions for them? Sure, but we have never filled them. The blame lies on the doctor’s who pander to the drug reps, and to the pharmacies who have no issue with filling these types of prescriptions.
It seems to me that the pharmaceuticals are not playing the “game” very wisely.
After all, there is nothing wrong with off-label usage per se (if a doctor prescribes it), but there is a problem when the pharmaceutical promotes it.
Off-label marketing is yet another example of where paid KOLs and sales representatives are the wrong people at the front line. Doctors, who prescribe off-label, can do so if they wish — just don’t pay, remunerate, or script them.
But, if doctors who prescribe Fentora off-label just so happen to tell their physician colleagues how well it works and their patients tell other patients, who can stop them including the FDA — after all, that’s just word of mouth. Sounds like an “issue” that social media was built for.
Well, the simple truth is that both ends abuse the system; and the result is that people with legitimately serious pain end up undermedicated, while a significant fraction of the population keep up a cottage industry of diverting pharmaceutical company products to the non-prescription market. And so we satisfy our need to “do something” without the tremendous hassle of doing something effective.