Big Pharma Works The “Off-Label” Drug Dodge

risperdalThe Murdoch Street Journal opined today on a case in which Janssen Pharmaceuticals was named in an action by the state of Pennsylvania over Janssen’s antipsychotic drug Risperdal. The state alleges that Janssen has improperly marketed the drug for off-label uses not approved by the Food and Drug Administration, according to the Journal (Janssen denies this).

Well, on second thought, I should back up a minute here; the Journal actually uses this story as an excuse to publicize Janssen’s rather interesting legal strategy (the Journal doesn’t really care about what’s at issue here, truth be told, or else they wouldn’t have said anything).

See, Janssen is instead going after the office of Governor Ed Rendell and the law firm of Bailey, Perrin & Bailey contracted to handle the litigation, alleging some kind of a “pay to play” scheme that bypassed the state legislature.

And we wouldn’t be talking about the Journal unless we read lines like these, of course…

Asked why the Governor thought the case should be handled by his office rather than by the state AG, (Rendell spokesman Chuck) Ardo says, “the suit involves agencies directly under the Governor’s control, and the General Counsel’s Office believed it could eliminate a lot of unnecessary work by dealing with those agencies directly.” Readers can decide if they buy that one.

State prosecutors are supposed to be motivated by a sense of public responsibility for the interests of justice. Law firms have other motivations…

Hope the Journal’s Op-Ed writers have fun polishing those stones in their glass house, if you know what I mean.

More to the point, though, this tells us more about the issue at hand, including this excerpt…

“Off-label marketing is a sort of skinflint, cheap way of promoting drugs without doing the research needed to get the approval of the FDA for new uses,” said Sidney Wolfe, director of Public Citizen’s Health Research Group, a Washington-based advocacy organization. “Companies that do this place patients at risk because there is no assurance that the benefits outweigh the risks.”

The reason the state of Pennsylvania is suing Janssen over “off-label” use of Risperdal is because of the potential for life-endangering uses of “off-label” drugs, which can be marketed to a wider, more diverse audience in terms of age and medical history than originally intended (which, as of this 2007 article, seemed to be fine with the FDA, though we’ll see what happens in the event that former Kansas Gov. Kathleen Sebelius is named as Heath and Human Services Secretary and a new FDA head is appointed).

Here and here are articles detailing the potential for abuse of drugs designated as “off-label,” and here is more on the “off-label” sale of Risperdal and Zyprexa.

In the meantime, I will look forward to the same level of scrutiny of the Janssen trial from the Journal as they gave to the pre-trial machinations of the defendant, and I hope I won’t be disappointed.

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2 Responses to Big Pharma Works The “Off-Label” Drug Dodge

  1. jane says:

    Off-label promotion is done on a DAILY basis with representatives. Big pharma gives the “impression” that they deter off-label promotion by their representatives. The reality is that they turn their back to it.

    If an investigation is initiated by the company due to an allegation, it usually takes months before it is resolved. Often it is the innocent informant who is retaliated against while the offending person or persons, are met with mild disciplinary action. Even when one has clear and convincing evidence, there is little done.

    In todays world, off-label promotion is much more common than the FDA, DOJ or AG believe. All they need to do is place someone in an office and they will hear many times throughout the day representatives promoting both illegally and unethically. To many Big Pharma companies and Sales Operations, it is all about the profits. They may lead you to believe that they are following code, but if these agencies were to randomly select sales representatives throughout the country, they would see how widespread and how unethical some of the pharma reps are.

    The truth is, the majority of representatives are unethlical, sleaze mongers. Gone are the day of the honest pharmaceutical representative that is truly there for the physician and the patient.

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