Stephen Stahl + Lurasidone: The Hired Guns Come to Town

Just when you thought we had reached the point of antipsychotic supersaturation, yet another me-too drug is edging its way into this $20 billion market. The drug is Lurasidone, and the company is Sunovion (formerly Sepracor). FDA approval is likely by the end of this year, and in anticipation Sunovion has begun a marketing blitz, tossing so much money at hired guns that it looks like confetti. And where there is drug company money to be had, Stephen Stahl is never far behind.

Lurasidone is simply another antipsychotic—no more, no less. The two major clinical trials (Pearl 1 and Pearl 2) have shown inconsistent efficacy results, high rates of side effects such as akathisia (restlessness), parkinsonism (tremor and stiffness), and sedation, and apparent inferiority to Zyprexa. Like several of the newer antipsychotics (such as Ability, Geodon, and Fanapt), Lurasidone causes little weight gain and few metabolic abnormalities. With no clear advantages over its many competitors, Lurasidone will succeed or fail based purely on the strength of its promotional campaign.

Which is why Sunovion has hired the impresario of drug company-funded education, Stephen Stahl, as their chief hired gun.

Stahl is the driving force behind a road show of Sunovion-funded “programs” entitled “Schizophrenia: Building Awareness—Advancing Understanding.” I first started receiving flyers for these lectures in July, and I get a new one every week or so. I’ve scanned some of them into my computer and have posted them on Evernote here.

The most recent promo piece came a couple of days ago, in the form of an email from Stephen Stahl himself. It started this way:

"To my fellow Boston area Psychopharmacologists:

Just a head's up about a local educational program I hope you can attend related to schizophrenia. The content is based both upon my textbook, Stahls Essential Psychopharmacology, and two cases from my private practice.”

Obviously aware of the increasing skepticism about pharma funding of physician education, Stahl addresses the issue head on: “ Although supported by Pharma and not CME (a new company Sunovion with a drug in the pipeline is the sponsor), there is no mention of any product here, just information on disease state, what I think is a very a cool update (understandable) on genomics, neuroimaging and the prodrome related to schizophrenia, and illustrated after the first didactic lecture with two cases taken from my practice.”

While I applaud Stahl’s transparency, I think he misunderstands the problem with pharma-funded programs. Their deficiency has nothing to do with the fact that they mention their drug, or any other drug. Why would a busy psychiatrist attend a half-day program on antipsychotics in which “there is no mention of any product”? In fact, we want to hear plenty about products. We look to experts like Stahl (and others on this tour, such as Leslie Citrome, Henry Nasrallah, Andrew Cutler, and Steve Potkin) to help us navigate the increasingly confusing terrain of antipsychotics.

We want them to talk about products, and we want specific recommendations. What is their first choice of antipsychotics and why? What are their second and third choices? What do they think about the increasing popularity of conventional antipsychotics? In their heart of hearts, do they really think that Lurasidone is worth choosing over its competitors? Shouldn’t we be hesitant to try me-too medications, when others of equal efficacy have long track records and clinical experience?

I predict that none of these experts will address these painfully obvious questions. Because if they did, they might let it slip that risperidone is their drug of choice. Or Abilify. Or Trilafon. Or Some Other Drug That Is Not Lurasidone.

Instead, audience members will hear about purely hypothetical mechanisms of action, many of which will be presented in such a way that Lurasidone will appear to have a "potential" advantage over its competitors.

This, after all, is the marketing strategy that Stahl has pioneered. Keep the audience mesmerized with colorful cartoons of fancy mechanisms of action that have no proven connection to the drug’s clinical action. Then say that because of these mechanisms of action, the sponsored drug “might” or “should” or “could potentially” or “will theoretically” be the best thing since Fridays.

Yesterday, Stahl’s CME company, NEI, sent me a free booklet, “Psychosis and Schizophrenia: Thinking It Through.” Like his road show, this book is funded by Sunovion, and it contains a coyly phrased endorsement of Lurasidone that is vintage Stahl: “Actions at 5HT7 and 5HT1A receptors suggest potential antidepressant and pro-cognitive actions, but this requires confirmation in clinical trials and real world clinical experience” (page 43).

Sorry for the poor review, Steve. But as Randy Jackson says on American Idol, “I’m just tryin’ to keep it real, dog.”