1 Boring Old Man

• there’s a long history of erroneous attempts at solving what seems the impossible dilemma when entrepreneurialism collides with rational health care and medical ethics, and the territory between scorched earth and sleeping with the enemy remains to be defined.
• Why have so many attempts at reform met with such regular failure?
• …no matter what we do, it has to include both the resources and the  mandate for oversight – indefinite, ongoing oversight. No more honor system and grand rhetoric. There’s just not enough honor in the marketplace to get the job done.
• Companies don’t commit fraud – people do. It’s part of that "cost of doing business" argument that’s so regularly mentioned that it’s become a figure of speech. This is the door we haven’t opened that can’t continue to stay closed.
• …there’s plenty of out-right crime accompanying the distortions in clinical trial reporting, libraries filled with incriminating subpoenaed documents, but no punishment of the perpetrators on the books. The only pertinent question here is why hasn’t it happened?

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Reading this now, I wonder why the approval was so broad ["management of the manifestations of psychotic disorders"] to start with. It was twenty years ago, and I think that’s the way most people were thinking about the antipsychotics then, but even at that, it seems like a blanket approval and we know it’s exactly what Janssen had in mind. To quote sales rep Tone Jones from the Texas trial, "You can’t be a billion dollar drug in a 1% market." Schizophrenia is that 1% market, and Janssen had its sights set much higher. In a later communication, the FDA confirmed the breadth of the Approval, but cautioned about the elderly once again, and insisted that Janssen note that the studies were done in short-term Schizophrenia trials. Then, in 1999, the FDA reviewed what Janssen was actually doing and issued a fairly firm "halt" order:

^{DDMAC = Division of Drug Marketing, Advertising and Communication [FDA]}

The back story here is that Janssen was cutting all kinds of deals to get Risperdal on the formularies and prescribed in beaucoups nursing homes. I’m going to leave you to look at that part yourself, but think Omnicare and think really big money. The FDA Approval probably was too broad in the first place. I think they were thinking about adults, where antipsychotics used in Schizophrenia have long been used for other conditions – like Acute Mania. But the FDA left a crack in the door for treating kids and the aged, and Janssen was racing through it by this time. When cautioned, Janssen pushed back, relying on the original wording, but they had also played it straight and applied for approval in the elderly. The FDA said "no," and brought up unexplained deaths:

So by 1999, the FDA had said "no" to dementia and had issued a threat. Selling Risderdal® as a treatment in dementia was not okay. Maybe there was a loophole to start with, but no longer. In fact, in March 2002, the FDA changed the approved indication to "treatment of Schizophrenia [see item 26 in the complaint].

What happened next is easily summarized [see pages 9 and 10 in the complaint]. In March 2003 the FDA requested a warning on the label about increased risk of stroke in the elderly, and added another in November, 2003 about Diabetes. In December, 2003 the FDA approved Risderdal® for short term treatment of Mania. Finally, in April 2005, the FDA required a Black Box Warning for all Atypical Antipsychotics, highlighting the risk of increased mortality in elderly patients with dementia-related psychosis. And the following month, they turned down yet another request for Risderdal®’s use in the elderly, this time in Alzheimer’s disease.

In summarizing, the FDA cut them some slack and didn’t complain about Janssen’s opportunizing on a loophole. What they don’t say is that Janssen was pushing Risderdal® for agitation, hostility, psychosis, etc, all the while getting it onto eldercare facilities’ formularies. In many places, Risderdal® was almost a routine drug in these institutions. Janssen was raking in the money from this enterprise throughout this whole story.

The behavior of Janssen was unaffected by these actions of the FDA. Their marketing Risderdal® for the elderly, if anything, escalated as the FDA continued to try to get it under control.

They recommended Risderdal® for non-psychotic behaviors for which it was never approved, and continued to push it for psychotic symptoms after the drug’s indications were refined to specifically discourage this use. And they knew what they were doing the whole time.

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I apologize for the length of this post. I just couldn’t think of any way to shorten it. There are several points I’m trying to make. Janssen knew what it was doing. The FDA may have been slower than we would’ve have liked, but they were clear – and Janssen just kept on going. The dangers of Risderdal® to elderly patients became increasingly clear – and Janssen just kept on going. When things were coming to a head: the FDA was after their Eldercare plans; Allen Jones had filed his TMAP suit; the man in charge of Risderdal®, Alex Gorsky who headed the Risderdal® operation, had exited to Europe – and Janssen just kept on going. Nothing stopped them and this settlement won’t stop them if they’re in a similar situation in the future. The money is just too big. So I stand by "There’s just not enough honor in the marketplace to get the job done" and there never will be. And whatever we are doing now isn’t enough to get the job done either. The FDA and the DOJ gave it the old college try here.

• First, in our negotiations with the pharmaceutical industry [and the KOLs], I’m closer to scorched earth than on any other issue I can think of. I’m not a scorched-earth kind of guy, but it’s clear that no matter what they say or even what they mean now, in the heat of battle when they can smell the profits, this story is typical of how they act – over and over – all of them. It’s not a question of trust. It’s evidence based!
• Second. This story is missing teeth. Put the executives in jail [and the KOLs]. Take all the ill-gotten profit instead of a piece. Pull the drug’s patent protection. Do whatever it takes to stop the game playing with people’s health and lives. When we work with adolescents, we try to rehabilitate them, but at some point we throw in the towel, and it’s off to juvey. Our jails aren’t that overcrowded. There’s room for plenty of these guys…