a 1% market…

Posted on Wednesday 19 September 2012

It’s worth thinking about why the Texas Medical Algorithm Program [TMAP] program doesn’t come up more frequently these days. It was, by any accounting, both the most elaborate and the most devious of the psychotropic pharmaceutical marketing schemes of all. When Risperdal was introduced, it came into a ready made market. The side effects of the antipsychotics made the available drugs difficult to use and the only alternative, Clozaril, was toxic to the bone marrow and killed people. Risperdal looked to be a non-lethal Clozaril. Janssen’s only problem was that the target population, Schizophrenic patients, are largely treated in the cost conscious State Mental Health systems funded through Medicaid programs. So J&J funded a Tri-University group to create an ALGORITHM for treatment by surveying a panel of experts. No surprise, they picked Risperdal as a first line drug. Then J&J funded John Rush’s TMAP program to create an ALGORITHM for the State of Texas programs using the Tri-University ALGORITHM. And then they paid Stephen Shon, Director of Texas Mental Health to fly around spreading the TMAP gospel to other States and George W. Bush took it to Washington. And so, in public systems, Risperdal [followed by the other Atypical Antipsychotics] became the drug of the hour [bringing Texas Medicaid to the brink of bankruptcy].

If you look at Alex Gorsky’s job history with J&J in my last post, you might notice that he came on to the fast track about the same time Risperdal hit the market, and he was, indeed, involved in the drug’s rise into the ranks of the all-time blockbuster – they rose together. But sliding into the public market wasn’t enough. There was a witness in the final day of the Texas TMAP trial that made a big impression on me. He was a former Janssen sales rep, but he wasn’t defensive or evasive like the others. Here’s what I wrote about Tone Jones when I got home:
On what would be the final day of the trial, we saw a video deposition of Tone Jones. He was a District Sales Manager in Houston from 2002 – 2009. Tone was recruited to Janssen right out of college when he didn’t make it to the NFL [quarterback for Oklahoma]. Out of the gate, he was a different witness. The Janssen lawyers had approached him as with Ms. Moake – paid testimony, represent him in the deposition, said something about company loyalty as a previous employee. He was offended and said "no." Later, when he was approached by the plaintiff’s lawyer, they offered him nothing, and he said "yes."

He answered the questions in an unemotional, matter-of-fact way – and his answers were quietly damning, famously saying, "You can’t be a billion dollar drug in a 1% market." They showed a training memo from his top Sales Rep, Laura Haughn, that said: "Child and Adolescent Psychiatrists", "Provide with treatment under 13", "Most diagnosed with behavior disorders or mood disorders", "No indications!!!", "Sell on symptoms not diagnosis". Did they target Medicaid? "Yes". Why? "Big Payer". Did they target the Drug Utilization Board? "Yes". Did they target the Pharmacy and Therapeutics Committee? "Yes". Did he recruit speakers? "Yes". Did they downplay the incidence of Diabetes? "Yes". Even after the warning letter? "Yes". How often? "On every call". Were all sales messages approved by Janssen? "Yes". Were these sales directives local or national? "National". They showed him an organizational chart of the Janssen Sales Department and an email chain about selling Risperdal for children that traveled all the way to the top and down again. His testimony was delivered quietly, but it was devastating [and sounded truthful].

So they actively moved into the child and adolescent market without FDA Approval selling off-label "on every call." Did Alex Gorsky know about TMAP and Shon’s selling it nationally? What Shon said in Texas:


[reformatted to fit]

Did Gorsky know about TMAP? Damn right he knew. He got a private progress report. Was he involved in making TMAP happen? Way more likely than not. How about off-label promotion to kids? Of course he knew. How could he not know? What about Biederman’s Bipolar epidemic and the J&J Center? Sure he knew. How could he not? But last night when I wrote, "Hardly up to West Point Honor Code, the Ranger’s Creed, the J&J Credo, or the Boy Scout Oath", I felt kind of guilty about holding those things up to him. I even looked them up and linked them. Was I being too harsh, pointing out the numerous oaths of honesty Alex Gorsky has sworn over his lifetime? Later, I ran across this mention of an award – Honorable Mentor.
“I have always believed a leader’s performance is best judged by how many individuals he or she has personally touched and developed along the way and, throughout my career, I have aspired to be that kind of leader,” said Mr. Gorsky, who serves on the HBA Global Advisory Board. I am humbled to be named Honorable Mentor this year by the Healthcare Businesswomen’s Association, and am very proud to be associated with this strong industry organization that nurtures and inspires women to lead others.”

The HBA created the Honorable Mentor Award in 2001 to recognize one individual each year who demonstrates long-term support of the advancement of women in the healthcare industry, has a personal dedication to developing, mentoring and promoting women in the industry, and who has been supportive of the HBA.  “Alex was selected as the 2009 HBA Honorable Mentor because of his deep personal commitment to the advancement of women in the healthcare industry," said Ceci Zak, President of the Healthcare Businesswomen’s Association. “We are grateful for all of his contributions to our organization and to the countless women he has motivated, mentored and encouraged to be great leaders in business.”

Well I’m over my guilt today. If I’m going to be mad at physicians for betraying the Hippocratic Oath and taking advantage of Aesculapian Authority [and I am], why shouldn’t I hold Alex Gorsky to the oaths he took all along the way? to the lofty ethics in his own speeches? So I went back and reread that testimony I was talking about yesterday – Alex Gorsky’s Deposition in May 2012 – thinking I might could do a better job of extracting what he said because I doubt that most people have the stomach to read all 66 pages. But I was no more able to find something of value than the first time through. Every answer was contrived to avoid or deny the meaning of the question. I understand that he has the right to refuse to incriminate himself, but he didn’t take that option. Instead, he spent his time creating fantastic meanings to simple questions or turning everything into mush. My best summary would be an oft quoted saying from my own father: "I don’t mind you peeing in my boot, but don’t tell me it’s water."

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